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3. Presence of procoagulant peripheral blood mononuclear cells in severe COVID-19 patients relate to ventilation perfusion mismatch and precede pulmonary embolism

Author

Raadsen, M., Langerak, T., Du Toit, J., Kruip, M.J.H.A., Aynekulu Mersha, D., De Maat, M.P.M., Vermin, B., Van den Akker, J.P.C., Schmitz, K.S., Bakhtiari, K., Meijers, J.C.M., van Gorp, E.C.M., Short, K.R., Haagmans, B., de Vries, R.D., Gommers, D.A.M.P.J., Endeman, H., and Goeijenbier, M.

Published
2024
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4. Towards optimal use of antithrombotic therapy of people with cancer at the end of life: A research protocol for the development and implementation of the SERENITY shared decision support tool

Author

Goedegebuur, J., Abbel, D., Accassat, S., Achterberg, W.P., Akbari, A., Arfuch, V.M., Baddeley, E., Bax, J.J., Becker, D., Bergmeijer, B., Bertoletti, L., Blom, J.W., Calvetti, A., Cannegieter, S.C., Castro, L., Chavannes, N.H., Coma-Auli, N., Couffignal, C., Edwards, A., Edwards, M., Enggaard, H., Font, C., Gava, A., Geersing, G.J., Geijteman, E.C.T., Greenley, S., Gregory, C., Gussekloo, J., Hoffmann, I., Højen, A.A., van den Hout, W.B., Huisman, M.V., Jacobsen, S., Jagosh, J., Johnson, M.J., Jørgensen, L., Juffermans, C.C.M., Kempers, E.K., Konstantinides, S., Kroder, A.F., Kruip, M.J.H.A., Lafaie, L., Langendoen, J.W., Larsen, T.B., Lifford, K., van der Linden, Y.M., Mahé, I., Maiorana, L., Maraveyas, A., Martens, E.S.L., Mayeur, D., van Mens, T.E., Mohr, K., Mooijaart, S.P., Murtagh, F.E.M., Nelson, A., Nielsen, P.B., Ording, A.G., Ørskov, M., Pearson, M., Poenou, G., Portielje, J.E.A., Raczkiewicz, D., Rasmussen, K., Trinks-Roerdink, E., Schippers, I., Seddon, K., Sexton, K., Sivell, S., Skjøth, F., Søgaard, M., Szmit, S., Trompet, S., Vassal, P., Visser, C., van Vliet, L.M., Wilson, E., Klok, F.A., and Noble, S.I.R.

Published
2023
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5. The upper extremity postthrombotic syndrome score: an international Delphi consensus study to determine the score’s functional disability component

Author

Schropp, L., Cats, R.B., de Kleijn, R.J.C.M.F., Black, S., Garcia, D., Meijer, K., Nijziel, M.R., Klappe, E.M., Geroulakos, G., van Ommen, C.H., van Rijn, M.J.E., Freischlag, J., Kruip, M.J.H.A., Huisman, M.V., Coppens, M., Teijink, J.A.W., Kakkos, S.K., Le Gal, G., Westerweel, P.E., Avila, M.L., Kreuziger, L. Baumann, Cate-Hoek, A.J. Ten, Lee, A.Y.Y., Koelemay, M.J., Srivastava, A., Hovens, M.M.C., Ünlü, Ç., Klok, F.A., Douketis, J., Stansby, G., Illig, K.A., Thompson, R.W., Bax, W.A., Poli, D., Kahn, S.R., van Hattum, E.S., Middeldorp, S., Nijkeuter, M., Westerink, J., Petri, B.J., de Borst, G.J., Schropp, Ludo, Cats, Roos B., de Kleijn, Robert J.C.M.F., van Hattum, Eline S., Middeldorp, Saskia, Nijkeuter, Mathilde, Westerink, Jan, Petri, Bart-Jeroen, and de Borst, Gert J.

Published
2023
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6. Lupus anticoagulant associates with thrombosis in patients with COVID‐19 admitted to intensive care units: A retrospective cohort study

Author

Noordermeer, Tessa, Schutgens, Roger E.G., Visser, Chantal, Rademaker, Emma, de Maat, Moniek P.M., Jansen, A.J. Gerard, Limper, Maarten, Cremer, Olaf L., Kruip, Marieke J.H.A., Endeman, Henrik, Maas, Coen, de Laat, Bas, Urbanus, Rolf T., van de Beek, D., Brouwer, M.C., de Bruin, S., Coppens, M., van Es, N., van Haaps, T.F., Juffermans, N.P., Muller, M.C.A., Vlaar, A.P.J., Hertogh, C.M.P.M., Heunks, L.M.A., Hugtenburg, J.G., van Kooten, J., Nossent, E.J., Smulders, Y., Tuinman, P.R., Vonk Noordegraaf, A., Grootenboers, M.J.J.H., van Guldener, C., Kant, M., Lansbergen, A., Faber, J., Hajer, G., Stemerdink, A., van den Akker, J., Bierings, R., Endeman, H., Goeijenbier, M., Hunfeld, N.G.M., van Gorp, E.C.M., Gommers, D.A.M.P.J., Koopmans, M.P.G., Kruip, M.J.H.A., Kuiken, T., Langerak, T., Leebeek, Lauw, M.N., de Maat, M.P.M., Noack, D., Paats, M.S., Raadsen, M.P., Rockx, B., Rokx, C., Schurink, C.A.M., Tong‐Minh, K., van den Toorn, L., den Uil, C.A., Visser, C., Boutkourt, F., Roest, T., Douma, R.A., de Haan, L.R., ten Wolde, M., Bemelmans, R.H.H., Festen, B., Stads, S., de Jager, C.P.C., Simons, K.S., Antoni, M.L., Bos, M.H., Burggraaf, J.L.I., Cannegieter, S.C., Eikenboom, H.C.J., den Exter, P.L., Geelhoed, J.J.M., Huisman, M.V., de Jonge, E., Kaptein, F.H.J., Klok, F.A., Kroft, L.J.M., Lijfering, W.M., Nab, L., Ninaber, M.K., Putter, H., Ramai, S.R.S., da Rocha Rondon, A.M., Roukens, A.H.E., Stals, M.A.M., Versteeg, H.H., Vliegen, H.W., van Vlijmen, B.J.M., van de Berg, T., Bruggemann, R., van Bussel, B.C.T., ten Cate, H., ten Cate‐Hoek, A., Hackeng, T.M., Henskens, ir.Y., Hulshof, A., Mulder, M., Olie, R.H., Schurgers, L., Spaetgens, B., Spronk, H., Winckers, K., Nieuwenhuizen, L., Franken, B., Schrover, I.M., de Waal, E.G.M., Beishuizen, A., Cornet, A., Krabbe, J., Kramers, K., Leentjens, J., de Mast, Q., Middeldorp, S., Brouwer, R.E., Ellerbroek, J.L.J., Tijmensen, J., Hovens, M.M C., Oostdijk, E.A.N., Westerhof, B.D., Faber, L.M., van den Biggelaar, M., Meijers, J.C.M., Voorberg, J., Kevenaar, M.E., Soei, Y.L., Wils, E.J., Croles, F.N., de Laat, B., Kamphuisen, P.W., Vink, R., Lisman, T., Meijer, K., van Tichelaar, Y.I.G., Cremer, O.L., Geersing, G., Kaasjager, H.A.H., Kusadasi, N., Huisman, A., Maas, C., Nijkeuter, M., Schutgens, R.E.G., Creveldkliniek, Van, Urbanus, R.T., Westerink, J., Faber, H.J., Koster, S.C.E., van Montfort, P., and van Twist, D.J.L.

Published
2022
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9. Incidence of thrombotic complications and overall survival in hospitalized patients with COVID-19 in the second and first wave

Author

Kaptein, F.H.J., Stals, M.A.M., Grootenboers, M., Braken, S.J.E., Burggraaf, J.L.I., van Bussel, B.C.T., Cannegieter, S.C., ten Cate, H., Endeman, H., Gommers, D.A.M.P.J., van Guldener, C., de Jonge, E., Juffermans, N.P., Kant, K.M., Kevenaar, M.E., Koster, S., Kroft, L.J.M., Kruip, M.J.H.A., Leentjens, J., Marechal, C., Soei, Y.L., Tjepkema, L., Visser, C., Klok, F.A., and Huisman, M.V.

Published
2021
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10. Major differences in clinical presentation, diagnosis and management of men and women with autosomal inherited bleeding disorders

Author

Atiq, F., Saes, J.L., Punt, M.C., van Galen, K.P.M., Schutgens, R.E.G., Meijer, K., Cnossen, M.H., Laros-Van Gorkom, B.A.P., Peters, M., Nieuwenhuizen, L., Kruip, M.J.H.A., de Meris, J., van der Bom, J.G., van der Meer, F.J.M., Fijnvandraat, K., Kruis, I.C., van Heerde, W.L., Eikenboom, H.C.J., Leebeek, Frank W.G., and Schols, S.E.M.

Published
2021
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14. One piece of the puzzle: Population pharmacokinetics of FVIII during perioperative Haemate P®/Humate P® treatment in von Willebrand disease patients

Author

de Jager, Nico C.B., Bukkems, Laura H., Heijdra, Jessica M., Hazendonk, Carolien H.C.A.M., Fijnvandraat, Karin, Meijer, Karina, Eikenboom, Jeroen, Laros - van Gorkom, Britta A.P., Leebeek, Frank W.G., Cnossen, Marjon H., Mathôt, Ron A.A., Collins, P.W., Kruip, M.J.H.A., Polinder, S., Lock, J., van Moort, I., Goedhart, M.C.H.J., Coppens, M., Peters, M., Preijers, T., Brons, P., van der Meer, F.J.M., Schutgens, R.E.G., Fischer, K., Driessens, M.H.E., Zwaan, C.M., van Vliet, I., Liesner, R., Chowdary, P., and Keeling, D.

Published
2020
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19. A Generative and Causal Pharmacokinetic Model for Factor VIII in Hemophilia A: A Machine Learning Framework for Continuous Model Refinement.

Author

Janssen, Alexander, Smalbil, Louk, Bennis, Frank C., Cnossen, Marjon H., Mathôt, Ron A. A., Cnossen, M.H., Mathôt, R.A.A., Leebeek, F.W.G., Coppens, M., Fijnvandraat, K., Meijer, K., Schols, S.E.M., Eikenboom, H.C.J., Schutgens, R.E.G., Heubel‐Moenen, F., Nieuwenhuizen, L., Ypma, P., Driessens, M.H.E., van Vliet, I., and Kruip, M.J.H.A.

Subjects
HEMOPHILIA, MACHINE learning, CAUSAL models, STANDARD deviations, BLOOD coagulation factor VIII, HEALTH facilities
Abstract

In rare diseases, such as hemophilia A, the development of accurate population pharmacokinetic (PK) models is often hindered by the limited availability of data. Most PK models are specific to a single recombinant factor VIII (rFVIII) concentrate or measurement assay, and are generally unsuited for answering counterfactual ("what‐if") queries. Ideally, data from multiple hemophilia treatment centers are combined but this is generally difficult as patient data are kept private. In this work, we utilize causal inference techniques to produce a hybrid machine learning (ML) PK model that corrects for differences between rFVIII concentrates and measurement assays. Next, we augment this model with a generative model that can simulate realistic virtual patients as well as impute missing data. This model can be shared instead of actual patient data, resolving privacy issues. The hybrid ML‐PK model was trained on chromogenic assay data of lonoctocog alfa and predictive performance was then evaluated on an external data set of patients who received octocog alfa with FVIII levels measured using the one‐stage assay. The model presented higher accuracy compared with three previous PK models developed on data similar to the external data set (root mean squared error = 14.6 IU/dL vs. mean of 17.7 IU/dL). Finally, we show that the generative model can be used to accurately impute missing data (< 18% error). In conclusion, the proposed approach introduces interesting new possibilities for model development. In the context of rare disease, the introduction of generative models facilitates sharing of synthetic data, enabling the iterative improvement of population PK models. [ABSTRACT FROM AUTHOR]

Published
2024
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22. Pregnancy-Adapted YEARS Algorithm for Diagnosis of Suspected Pulmonary Embolism

Author

van der Pol, L.M., Tromeur, C., Bistervels, I.M., Ni Ainle, F., van Bemmel, T., Bertoletti, L., Couturaud, F., van Dooren, Y.P.A., Elias, A., Faber, L.M., Hofstee, H.M.A., van der Hulle, T., Kruip, M.J.H.A., Maignan, M., Mairuhu, A.T.A., Middeldorp, S., Nijkeuter, M., Roy, P.M., Sanchez, O., Schmidt, J., Ten Wolde, M., Klok, F.A., and Huisman, M.V.

Published
2019
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23. Low and Highly Variable Exposure to Prophylactic LMWH Nadroparin in Critically Ill Patients: Back to the Drawing Board for Prophylactic Dosing?

Author

Diepstraten, J., Rongen, A., Zijlstra, M.P., Kruip, M.J.H.A., Heiden, P.L.J. van der, Heine, R. ter, Diepstraten, J., Rongen, A., Zijlstra, M.P., Kruip, M.J.H.A., Heiden, P.L.J. van der, and Heine, R. ter

Abstract

01 februari 2023, Item does not contain fulltext, BACKGROUND AND OBJECTIVE: Low-molecular-weight heparins are routinely administered to patients in the intensive care unit to prevent venous thromboembolisms. There is considerable evidence that low-molecular-weight heparin doses should be personalised based on anti-Xa levels, but pharmacokinetic data in intensive care unit patients are lacking. This study aimed to characterise the pharmacokinetics and associated variability of the low-molecular-weight heparin nadroparin in critically ill patients. METHODS: Critically ill adult patients who were admitted to the intensive care unit and received nadroparin for prophylaxis of venous thromboembolism were included in a study. Population pharmacokinetic analysis was performed by means of parametric non-linear mixed-effects modelling (NONMEM). RESULTS: A total of 30 patients were enrolled with 12 patients undergoing continuous veno-venous hemodialysis and 18 patients not undergoing continuous veno-venous hemodialysis. Very high variability in pharmacokinetics was observed with an inter-individual variability in the volume of distribution of 63.7% (95% confidence interval 46.5-90.6), clearance of 166% (95% confidence interval 84.7-280) and relative bioavailability of 40.2% (95% confidence interval 29.5-52.6). We found that standard doses of 2850 IE and 5700 IE of nadroparin resulted in sub-prophylactic exposure in critically ill patients. CONCLUSIONS: Low exposure and highly variable pharmacokinetics of nadroparin were observed in intensive care unit patients treated with a prophylactic dose. It can be debated whether nadroparin is currently dosed optimally in intensive care unit patients and our findings encourage the investigation of higher and tailored dosing of nadroparin in the critically ill.

Published
2023

24. Noninvasive diagnostic work-up for suspected acute pulmonary embolism during pregnancy: a systematic review and meta-analysis of individual patient data.

Author

Stals, M.A.M., Moumneh, T., Ainle, F.N., Aujesky, D., Bemmel, T. van, Bertoletti, L., Bistervels, I.M., Chauleur, C., Couturaud, F., Dooren, Y.P.A. van, Elias, A., Faber, L.M., Gall, C., Hofstee, H.M.A., Hulle, T. van der, Kruip, M.J.H.A., Maignan, M., Mairuhu, A.T.A., Middeldorp, S., Moigne, E. Le, Nijkeuter, M., Pol, L. van de, Robert-Ebadi, H., Roy, P.M., Sanchez, O., Schmidt, J., Smeden, M. van, Tromeur, C., Wolde, M.T., Righini, M., Gal, G. Le, Huisman, M.V., Klok, F.A., Stals, M.A.M., Moumneh, T., Ainle, F.N., Aujesky, D., Bemmel, T. van, Bertoletti, L., Bistervels, I.M., Chauleur, C., Couturaud, F., Dooren, Y.P.A. van, Elias, A., Faber, L.M., Gall, C., Hofstee, H.M.A., Hulle, T. van der, Kruip, M.J.H.A., Maignan, M., Mairuhu, A.T.A., Middeldorp, S., Moigne, E. Le, Nijkeuter, M., Pol, L. van de, Robert-Ebadi, H., Roy, P.M., Sanchez, O., Schmidt, J., Smeden, M. van, Tromeur, C., Wolde, M.T., Righini, M., Gal, G. Le, Huisman, M.V., and Klok, F.A.

Abstract

Item does not contain fulltext, BACKGROUND: Few studies evaluated the performance of noninvasive diagnostic strategies for suspected acute pulmonary embolism (PE) in pregnant women. OBJECTIVES: The aim of this study was to establish the safety and efficiency of the Wells rule with fixed and adapted D-dimer threshold, and the YEARS algorithm, combined with compression ultrasonography (CUS), in pregnant women with suspected PE in an individual patient data meta-analysis. METHODS: We performed a systematic review to identify prospective diagnostic management studies in pregnant women with suspected PE. Primary outcomes were safety, defined as the failure rate, ie, the 3-month venous thromboembolism (VTE) incidence after excluding PE without chest imaging, and efficiency, defined as the proportion of patients in whom chest imaging could be avoided. RESULTS: We identified 2 relevant studies, of which individual patient-level data were analyzed in a fixed-effect meta-analysis, totaling 893 pregnant women. The Wells rule with fixed and adapted D-dimer threshold as well as the YEARS algorithm could safely rule out acute PE (failure rate, 0·37%-1·4%), but efficiency improved considerably when applying pretest probability-adapted D-dimer thresholds. The efficiency of bilateral CUS was limited (2·3% overall; number needed to test 43), especially in patients without symptoms of deep-vein thrombosis (efficiency 0·79%; number needed to test 127). CONCLUSION: This study supports the latest guideline recommendations (European Society of Cardiology 2019) to apply pretest probability assessment and D-dimer tests to rule out PE in pregnant women. From an efficiency perspective, the use of a strategy with pretest probability-adapted D-dimer threshold is preferred. The yield of CUS was very limited in patients without concomitant symptoms of deep-vein thrombosis.

Published
2023

25. Little discrepancy between one-stage and chromogenic factor VIII (FVIII)/IX assays in a large international cohort of persons with nonsevere hemophilia A and B.

Author

Zwagemaker, A.F., Kloosterman, F.R., Gouw, S.C., Boyce, S., Brons, P.P., Cnossen, M.H., Collins, P.W., Eikenboom, J., Hay, C., Hengeveld, R.C.C., Jackson, S., Klopper-Tol, C.A.M., Kruip, M.J.H.A., Laros-van Gorkom, B.A.P., Male, C., Nieuwenhuizen, L., Shapiro, S., Fijnvandraat, K., Coppens, M., Zwagemaker, A.F., Kloosterman, F.R., Gouw, S.C., Boyce, S., Brons, P.P., Cnossen, M.H., Collins, P.W., Eikenboom, J., Hay, C., Hengeveld, R.C.C., Jackson, S., Klopper-Tol, C.A.M., Kruip, M.J.H.A., Laros-van Gorkom, B.A.P., Male, C., Nieuwenhuizen, L., Shapiro, S., Fijnvandraat, K., and Coppens, M.

Abstract

01 april 2023, Item does not contain fulltext, BACKGROUND: Accurate measurements of coagulation factor activity form an essential part of hemophilia management and are performed by the one-stage or chromogenic assay. Current literature suggests that approximately one-third of persons with nonsevere hemophilia A exhibit assay discrepancy, albeit with a high variability between studies. Such data are scarce in nonsevere hemophilia B. OBJECTIVES: To investigate the extent of factor VIII/IX one-stage and chromogenic assay discrepancy in moderate and mild hemophilia A and B. METHODS: Persons with previously diagnosed nonsevere hemophilia A and B with a factor level of 2 to 35 IU/dL were included from the international DYNAMO cohort study. Central measurements of the factor VIII and IX activity levels were performed by the one-stage and chromogenic assay. Relative and absolute discrepancy definitions were used, with the International Society on Thrombosis and Haemostasis-Scientific and Standardization Committee proposed ratio of >2.0 or <0.5 being the primary outcome. Discrepancy was also evaluated in a subgroup of 13 persons with mutations previously associated with discrepancy (≥3 cases reported in literature). RESULTS: A total of 220 persons were included, of whom 3 (1%) showed assay discrepancy: 2/175 hemophilia A and 1/45 hemophilia B. Six persons (3%) exhibited an absolute difference >10 IU/dL between the assay results. In addition, with more lenient definitions, over 90% of participants (n = 197) had no discrepant results. Only 1 out of 13 persons with a mutation previously associated with discrepancy had significant assay discrepancy. CONCLUSION: Little assay discrepancy was observed despite the presence of mutations previously associated with discrepancy, suggesting that the presence and magnitude of assay discrepancy are largely determined by laboratory variables.

Published
2023

26. Chronic thromboembolic pulmonary hypertension and clot resolution after COVID-19-associated pulmonary embolism.

Author

Jong, C.M.M. de, Visser, Chantal, Bemelmans, R.H.H., Boersma, W.G., Borst, B. van den, Burggraaf, J.L., Cannegieter, S.C., Cate-Hoek, A.J. Ten, Croles, F.N., Faber, H.J., Faber, L.M., Hellemons, M.E., Hessels, L.M., Huisman, M.V., Kamphuisen, P.W., Koster, S.C.E., Kroft, L.J., Lee, I. van der, Leentjens, J., Meijer, K, Ninaber, M.K., Sondermeijer, B.M., Stads, S., Vonk Noordegraaf, A., Winckers, K., Kruip, M.J.H.A., Klok, F.A., Jong, C.M.M. de, Visser, Chantal, Bemelmans, R.H.H., Boersma, W.G., Borst, B. van den, Burggraaf, J.L., Cannegieter, S.C., Cate-Hoek, A.J. Ten, Croles, F.N., Faber, H.J., Faber, L.M., Hellemons, M.E., Hessels, L.M., Huisman, M.V., Kamphuisen, P.W., Koster, S.C.E., Kroft, L.J., Lee, I. van der, Leentjens, J., Meijer, K, Ninaber, M.K., Sondermeijer, B.M., Stads, S., Vonk Noordegraaf, A., Winckers, K., Kruip, M.J.H.A., and Klok, F.A.

Abstract

01 april 2023, Item does not contain fulltext, The results of this study suggest that CTEPH is not a more common long-term complication after COVID-19-associated PE than after PE in non-COVID-19 patients, and thrombus resolution did not seem to be different from non-COVID-19-associated PE https://bit.ly/3IjvWL3

Published
2023

27. Decompressive surgery in cerebral venous sinus thrombosis due to vaccine-induced immune thrombotic thrombocytopenia.

Author

Krzywicka, K., Aguiar de Sousa, D., Cordonnier, C., Bode, F.J., Field, T.S., Michalski, D., Pelz, J., Skjelland, M., Wiedmann, M., Zimmermann, J., Wittstock, M., Zanotti, B., Ciccone, A., Bandettini di Poggio, M., Borhani-Haghighi, A., Chatterton, S., Aujayeb, A., Devroye, A., Dizonno, V., Geeraerts, T., Giammello, F., Günther, A., Ichaporia, N.R., Kleinig, T., Kristoffersen, E.S., Lemmens, R., Maistre, E. De, Mirzaasgari, Z., Payen, J.F., Putaala, J., Petruzzellis, M., Raposo, N., Sadeghi-Hokmabadi, E., Schoenenberger, S., Umaiorubahan, M., Sylaja, P.N., Munckhof, A. van de, Sanchez van Kammen, M., Lindgren, E., Jood, K., Scutelnic, A., Heldner, M.R., Poli, S., Kruip, M.J.H.A., Arauz, A., Conforto, A.B., Aaron, S., Middeldorp, S., Tatlisumak, T., Arnold, M., Coutinho, J.M., Ferro, J.M., Krzywicka, K., Aguiar de Sousa, D., Cordonnier, C., Bode, F.J., Field, T.S., Michalski, D., Pelz, J., Skjelland, M., Wiedmann, M., Zimmermann, J., Wittstock, M., Zanotti, B., Ciccone, A., Bandettini di Poggio, M., Borhani-Haghighi, A., Chatterton, S., Aujayeb, A., Devroye, A., Dizonno, V., Geeraerts, T., Giammello, F., Günther, A., Ichaporia, N.R., Kleinig, T., Kristoffersen, E.S., Lemmens, R., Maistre, E. De, Mirzaasgari, Z., Payen, J.F., Putaala, J., Petruzzellis, M., Raposo, N., Sadeghi-Hokmabadi, E., Schoenenberger, S., Umaiorubahan, M., Sylaja, P.N., Munckhof, A. van de, Sanchez van Kammen, M., Lindgren, E., Jood, K., Scutelnic, A., Heldner, M.R., Poli, S., Kruip, M.J.H.A., Arauz, A., Conforto, A.B., Aaron, S., Middeldorp, S., Tatlisumak, T., Arnold, M., Coutinho, J.M., and Ferro, J.M.

Abstract

Item does not contain fulltext, BACKGROUND AND PURPOSE: Cerebral venous sinus thrombosis due to vaccine-induced immune thrombotic thrombocytopenia (CVST-VITT) is an adverse drug reaction occurring after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. CVST-VITT patients often present with large intracerebral haemorrhages and a high proportion undergoes decompressive surgery. Clinical characteristics, therapeutic management and outcomes of CVST-VITT patients who underwent decompressive surgery are described and predictors of in-hospital mortality in these patients are explored. METHODS: Data from an ongoing international registry of patients who developed CVST within 28 days of SARS-CoV-2 vaccination, reported between 29 March 2021 and 10 May 2022, were used. Definite, probable and possible VITT cases, as defined by Pavord et al. (N Engl J Med 2021; 385: 1680-1689), were included. RESULTS: Decompressive surgery was performed in 34/128 (27%) patients with CVST-VITT. In-hospital mortality was 22/34 (65%) in the surgical and 27/94 (29%) in the non-surgical group (p < 0.001). In all surgical cases, the cause of death was brain herniation. The highest mortality rates were found amongst patients with preoperative coma (17/18, 94% vs. 4/14, 29% in the non-comatose; p < 0.001) and bilaterally absent pupillary reflexes (7/7, 100% vs. 6/9, 67% with unilaterally reactive pupil, and 4/11, 36% with bilaterally reactive pupils; p = 0.023). Postoperative imaging revealed worsening of index haemorrhagic lesion in 19 (70%) patients and new haemorrhagic lesions in 16 (59%) patients. At a median follow-up of 6 months, 8/10 of surgical CVST-VITT who survived admission were functionally independent. CONCLUSIONS: Almost two-thirds of surgical CVST-VITT patients died during hospital admission. Preoperative coma and bilateral absence of pupillary responses were associated with higher mortality rates. Survivors often achieved functional independence.

Published
2023

28. Colorectal cancer screening in patients with inherited bleeding disorders: high cancer detection rate in hemophilia patients.

Author

Kempers, E.K., Kwawegen, C.B. van, Meris, J. de, Spaander, M.C., Schols, S.E.M., Ypma, P.F., Heubel-Moenen, F.C.J.I., Vulpen, L.F. van, Coppens, M., Bom, J.G. van der, Fijnvandraat, K., Meijer, K, Eikenboom, J., Gouw, S.C., Leebeek, F.W.G., Kruip, M.J.H.A., Kempers, E.K., Kwawegen, C.B. van, Meris, J. de, Spaander, M.C., Schols, S.E.M., Ypma, P.F., Heubel-Moenen, F.C.J.I., Vulpen, L.F. van, Coppens, M., Bom, J.G. van der, Fijnvandraat, K., Meijer, K, Eikenboom, J., Gouw, S.C., Leebeek, F.W.G., and Kruip, M.J.H.A.

Abstract

Item does not contain fulltext, BACKGROUND: The population-based colorectal cancer (CRC) screening program in individuals aged 55 to 75 years in the Netherlands uses fecal immunochemical testing (FIT), to detect hemoglobin in feces, followed by colonoscopy in individuals with a positive FIT. OBJECTIVES: The objectives of this study are to assess the false-positive rate, detection rate, and positive predictive value of FIT for CRC and advanced adenoma (AA) in patients with Von Willebrand disease (VWD) or hemophilia. METHODS: We performed a multicenter, nationwide cross-sectional study embedded in 2 nationwide studies on VWD and hemophilia in the Netherlands. RESULTS: In total, 493 patients with hemophilia (n = 329) or VWD (n = 164) were included, of whom 351 patients participated in the CRC screening program (71.2%). FIT positivity and false-positive rate in patients with hemophilia and VWD were significantly higher than those in the general population (14.8% vs. 4.3%, p < .001 and 10.3% vs. 2.3%, p <.001, respectively). In patients with hemophilia, the detection rate of CRC/AA was significantly higher than that in the general male population (4.5% vs. 1.8%, p = .02), and the positive predictive value of FIT for CRC/AA was comparable (32.3% vs. 39.7%, n.s.). In patients with VWD, the detection rate was similar to that of the general population (0.8% vs. 1.4%, n.s.), whereas the positive predictive value was significantly lower than that in the general population (6.3% vs. 36.8%, p = .02). CONCLUSION: This study indicates that despite a high false-positive rate of FIT in patients with inherited bleeding disorders, the detection rate of CRC and/or AA in hemophilia patients is high. FIT performs different in patients with hemophilia or VWD compared with the general population.

Published
2023

29. Verbetering van de diagnostiek en behandeling van personen met een onverklaarde bloedingsneiging in Nederland

Author

Monard, A.L.L., Mussert, C.M.A., Henskens, Y.M.C., Kruip, M.J.H.A., Schutgens, R.E.G., Schols, S.E.M., Fijnvandraat, K.J., Meijer, K, Exter, P.L. den, Nieuwenhuizen, L., Moort, I. van, Biggelaar, M. van den, Duijl, T.T. van, Cnossen, M.H., Heubel-Moenen, F.C.J.I., Monard, A.L.L., Mussert, C.M.A., Henskens, Y.M.C., Kruip, M.J.H.A., Schutgens, R.E.G., Schols, S.E.M., Fijnvandraat, K.J., Meijer, K, Exter, P.L. den, Nieuwenhuizen, L., Moort, I. van, Biggelaar, M. van den, Duijl, T.T. van, Cnossen, M.H., and Heubel-Moenen, F.C.J.I.

Abstract

Item does not contain fulltext

Published
2023

30. Desmopressin in nonsevere hemophilia A: patient perspectives on use and efficacy

Author

Romano, L.G.R., Vulpen, L.F.D. van, Exter, P.L. den, Heubel-Moenen, F., Hooijmeijer, H.L., Coppens, M., Fijnvandraat, K., Schols, S.E.M., Ypma, P.F., Smit, C., Driessens, M.H.E., Rosendaal, Frits R., Bom, J.G. van der, Gouw, S.C., Kruip, M.J.H.A., Romano, L.G.R., Vulpen, L.F.D. van, Exter, P.L. den, Heubel-Moenen, F., Hooijmeijer, H.L., Coppens, M., Fijnvandraat, K., Schols, S.E.M., Ypma, P.F., Smit, C., Driessens, M.H.E., Rosendaal, Frits R., Bom, J.G. van der, Gouw, S.C., and Kruip, M.J.H.A.

Abstract

Item does not contain fulltext, BACKGROUND: Desmopressin increases plasma factor VIII and von Willebrand factor levels in persons with nonsevere hemophilia A. Patients' perspectives on desmopressin are relevant to increase and optimize its suboptimal use. However, patients' views on desmopressin are not reported. OBJECTIVES: To evaluate the perspectives of persons with nonsevere hemophilia A on desmopressin use, barriers for its use, side effects, and their knowledge about desmopressin's efficacy and side effects. METHODS: Persons with nonsevere hemophilia A were included in a cross-sectional, national, multicenter study. Questionnaires were filled out by adult patients and children aged ≥12 years themselves. Caretakers filled out questionnaires for children aged <12 years. RESULTS: In total, 706 persons with nonsevere hemophilia A were included (544 mild, 162 moderate, [age range, 0-88 years]). Of 508 patients, 234 (50%) patients reported previous desmopressin use. Desmopressin was considered as at least moderately effective in 171 of 187 (90%) patients. Intranasal administration was the modality of choice for 138 of 182 (76%) patients. Flushing was the most reported side effect in 54 of 206 (26%) adults and 7 of 22 (32%) children. The most frequently reported advantage and disadvantage were the convenience of intranasal, out-of-hospital administration by 56% (126/227) and side effects in 18% (41/227), respectively. Patients' self-perceived knowledge was unsatisfactory or unknown in 28% (63/225). CONCLUSION: Overall, desmopressin was most often used intranasally and considered effective, with flushing as the most common side effect. The most mentioned advantage was the convenience of intranasal administration and disadvantage was side effects. More information and education on desmopressin could answer unmet needs in patients with current or future desmopressin treatment.

Published
2023

31. Use of the National Early Warning Score for predicting deterioration of patients with acute pulmonary embolism: a post-hoc analysis of the YEARS Study

Author

Bavalia, R., Stals, M.A.M., Mulder, F.I., Bistervels, I.M., Coppens, M., Faber, L.M., Hendriks, S.V., Hofstee, H.M.A., Huisman, M.V., Hulle, T. van der, Mairuhu, A.T.A., Kruip, M.J.H.A., Middeldorp, S., Klok, F.A., Hutten, B.A., Holleman, F., Internal Medicine, Medical Oncology, Public Health, Hematology, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, Amsterdam Reproduction & Development (AR&D), Graduate School, Amsterdam Cardiovascular Sciences, Epidemiology and Data Science, ACS - Diabetes & metabolism, APH - Aging & Later Life, APH - Health Behaviors & Chronic Diseases, General Internal Medicine, and Amsterdam Gastroenterology Endocrinology Metabolism

Subjects
critical care, pulmonary embolism, death, Emergency Medicine, clinical management, General Medicine, Critical Care and Intensive Care Medicine
Abstract

BackgroundThe Pulmonary Embolism Severity Index (PESI) and the simplified PESI (sPESI) are validated scores for mortality prediction in patients with pulmonary embolism (PE). National Early Warning Score (NEWS) is a general prognostic risk score for multiple clinical settings. We investigated whether the NEWS had a comparable performance with the PESI and sPESI, for predicting intensive care unit (ICU) admission and death in patients with acute PE.MethodsIn haemodynamically stable patients with confirmed PE from the YEARS Study (2013–2015), we evaluated the performance of the NEWS, PESI and sPESI for predicting 7-day ICU admission and 30-day mortality. Receiver operating characteristic curves were plotted and the area under the curve (AUC) was calculated.ResultsOf 352 patients, 12 (3.4%) were admitted to the ICU and 5 (1.4%) died. The AUC of the NEWS for ICU admission was 0.80 (95% CI 0.66 to 0.94) and 0.92 (95% CI 0.82 to 1.00) for 30-day mortality. At a threshold of 3 points, NEWS yielded a sensitivity and specificity of 92% and 53% for ICU admission and 100% and 52% for 30-day mortality. The AUC of the PESI was 0.64 (95% CI 0.48 to 0.79) for ICU admission and 0.94 (95% CI 0.87 to 1.00) for mortality. At a threshold of 66 points, PESI yielded a sensitivity of 75% and a specificity of 38% for ICU admission. For mortality, these were 100% and 37%, respectively. The performance of the sPESI was similar to that of PESI.ConclusionIn comparison with PESI and sPESI, NEWS adequately predicted 7-day ICU admission as well as 30-day mortality, supporting its potential relevance for clinical practice.

Published
2022

33. Measuring anxiety and depression in young adult men with haemophilia using PROMIS

Author

Heesterbeek, M.R., Luijten, M.A.J., Gouw, S.C., Limperg, P.F., Fijnvandraat, K., Coppens, M., Kruip, M.J.H.A., Eikenboom, J., Grootenhuis, M.A., Flens, G., Terwee, C.B., Peters, M., Haverman, L., ACS - Pulmonary hypertension & thrombosis, Epidemiology and Data Science, APH - Methodology, Pediatric surgery, VU University medical center, Internal medicine, Graduate School, Paediatric Psychosocial Care, Paediatric Pulmonology, APH - Mental Health, Paediatric Haematology, AII - Infectious diseases, Amsterdam Reproduction & Development (AR&D), Vascular Medicine, APH - Digital Health, and Hematology

Subjects
Male, Young Adult, Psychometrics, Depression, Humans, Hematology, General Medicine, Anxiety, Hemophilia A, Genetics (clinical)
Published
2022
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35. The factor VIII treatment history of non-severe hemophilia A

Author

Abdi, A., Kloosterman, F.R., Eckhardt, C.L., Male, C., Castaman, G., Fischer, K., Beckers, E.A.M., Kruip, M.J.H.A., Peerlinck, K., Mancuso, M.E., Santoro, C., Hay, C.R., Platokouki, H., Bom, J.G. van der, Gouw, S.C., Fijnvandraat, K., Hart, D.P., INSIGHT Study Grp, Interne Geneeskunde, MUMC+: MA Hematologie (9), RS: Carim - B01 Blood proteins & engineering, Graduate School, ACS - Pulmonary hypertension & thrombosis, Paediatric Haematology, ARD - Amsterdam Reproduction and Development, Landsteiner Laboratory, and Hematology

Subjects
Fviii activity, medicine.medical_specialty, congenital, hereditary, and neonatal diseases and abnormalities, CHILDREN, 030204 cardiovascular system & hematology, Severe hemophilia A, Severity of Illness Index, Hemostatics, DEFINITIONS, 03 medical and health sciences, 0302 clinical medicine, Primary outcome, Interquartile range, Internal medicine, hemic and lymphatic diseases, Hemarthrosis, medicine, Humans, In patient, Treatment history, Treatment timing, RISK, MILD HEMOPHILIA, Factor VIII, joint bleed, treatment, business.industry, HAEMOSTASIS, Hematology, Original Articles, factor VIII, Cohort, INHIBITOR DEVELOPMENT, Original Article, hemophilia A, hemorrhage, business, IX
Abstract

BACKGROUND: In patients with non-severe hemophilia A, we lack detailed knowledge on the timing of treatment with factor VIII (FVIII) concentrates. This knowledge could provide information about the expected treatment timing in patients with severe hemophilia A treated with non-replacement therapies. OBJECTIVE: To assess the FVIII treatment history in patients with non-severe hemophilia A. METHODS: Patients with non-severe hemophilia (baseline FVIII activity [FVIII:C] 2-40 IU/dL) were included from the INSIGHT study. The primary outcome was median age at first FVIII exposure (ED1). In a subgroup of patients for whom more detailed information was available, we analyzed the secondary outcomes: median age at first 20 EDs, annualized bleeding rate for all bleeds (ABR), joint bleeds (AJBR), and major spontaneous bleeds (ASmBR). RESULTS: In the total cohort (n = 1013), median baseline FVIII activity was 8 IU/dL (interquartile range [IQR] 4-15) and the median age at ED1 was 3.7 years (IQR 1.4-7.7). Median age at ED1 rose from 2.5 years (IQR 1.2-5.7) in patients with FVIII:C 2-5 IU/dL to 9.7 years (IQR 4.8-16.0) in patients with FVIII:C 25-40 IU/dL. In the subgroup (n = 104), median age at ED1, ED5, ED10, and ED20 was 4.0 years (IQR 1.4-7.6), 5.6 years (IQR 2.9-9.3), 7.5 years (IQR 4.4-11.3), and 10.2 years (IQR 6.5-14.2), respectively. Median ABR, AJBR, and ASmBR were 1.1 (IQR 0.5-2.6), 0.3 (IQR 0.1-0.7), and 0 (IQR 0-0), respectively. CONCLUSION: This study demonstrates that in non-severe hemophilia A, the age at first FVIII exposure increases with baseline FVIII:C and that major spontaneous bleeds rarely occur. ispartof: JOURNAL OF THROMBOSIS AND HAEMOSTASIS vol:18 issue:12 pages:3203-3210 ispartof: location:England status: published

Published
2020

36. The immediate effect of COVID-19 vaccination on anticoagulation control in patients using vitamin K antagonists

Author

Visser, C., Biedermann, J.S., Nierman, M.C., Meer, F.J.M. van der, Gulpen, A.J.W., Moors, Y.C.F., Cannegieter, S.C., Lijfering, W.M., Kruip, M.J.H.A., Dutch COVID Thrombosis Coalition, and Hematology

Subjects
Male, anticoagulants, Time Factors, Vitamin K, COVID-19 vaccines, Risk Assessment, SDG 3 - Good Health and Well-being, Predictive Value of Tests, Risk Factors, Ambulatory Care, Humans, International Normalized Ratio, Blood Coagulation, BNT162 Vaccine, Aged, Netherlands, Retrospective Studies, Aged, 80 and over, BNT162b2 vaccine, acenocoumarol, Vaccination, Hematology, Treatment Outcome, phenprocoumon, Female, Drug Monitoring
Abstract

Background In January 2021, the Dutch vaccination program against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was started. Clinical studies have shown that systemic reactions occur in up to 50% of vaccine recipients. Therefore, COVID-19 vaccination could affect anticoagulation control, potentially leading to an increased risk of thrombotic events and bleeding complications. Aims This article investigates whether the BNT162b2 vaccine affects anticoagulation control in outpatients using vitamin K antagonists (VKAs). Methods A case-crossover study was performed in a cohort of outpatient VKA users from four Dutch anticoagulation clinics who received a BNT162b2 vaccine. International normalized ratio (INR) results and VKA dosages before the first vaccination, the reference period, were compared with those after the first and second vaccination. Results A total of 3,148 outpatient VKA users were included, with a mean age (standard deviation) of 86.7 (8.7) years, of whom 43.8% were male, 67.0% used acenocoumarol, and 33.0% phenprocoumon. We observed a decrease of 8.9% of INRs within range in the standard intensity group (target INR 2.0–3.0). There was both an increased risk of supratherapeutic (odds ratio [OR] = 1.34 [95% confidence interval [CI] 1.08–1.67]) and subtherapeutic levels (OR = 1.40 [95% CI 1.08–1.83]) after first vaccination. In the high-intensity group (target INR 2.5–3.5), the risk of a supratherapeutic INR was 2.3 times higher after first vaccination (OR = 2.29 [95% CI 1.22–4.28]) and 3.3 times higher after second vaccination (OR = 3.25 [95% CI 1.06–9.97]). Conclusion BNT162b2 was associated with an immediate negative effect on anticoagulation control in patients treated with VKAs, so it is advisable to monitor the INR shortly after vaccination, even in stable patients.

Published
2022

39. Home Treatment Compared to Initial Hospitalization in Normotensive Patients with Acute Pulmonary Embolism in the Netherlands: A Cost Analysis

Author

Hendriks, S.V., Hout, W.B. van den, Bemmel, T. van, Bistervels, I.M., Eijsvogel, M., Faber, L.M., Hofstee, H.M.A., Hulle, T. van der, Sol, A.I. del, Kruip, M.J.H.A., Mairuhu, A.T.A., Middeldorp, S., Nijkeuter, M., Huisman, M.V., Klok, F.A., YEARS Investigators, Hematology, Graduate School, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, and AR&D - Amsterdam Reproduction & Development

Subjects
Male, 0301 basic medicine, medicine.medical_specialty, home treatment, pulmonary embolism, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], costs, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Cost Savings, Health care, medicine, Humans, In patient, Stroke, Netherlands, Duration of Therapy, business.industry, Hemodynamics, Health Care Costs, Venous Thromboembolism, Hematology, Middle Aged, Patient Acceptance of Health Care, medicine.disease, Home Care Services, Confidence interval, Pulmonary embolism, 030104 developmental biology, Emergency medicine, Cost analysis, Female, Triage, Home treatment, business, Cohort study, hospitalization
Abstract

Background Venous thromboembolism constitutes substantial health care costs amounting to approximately 60 million euros per year in the Netherlands. Compared with initial hospitalization, home treatment of pulmonary embolism (PE) is associated with a cost reduction. An accurate estimation of cost savings per patient treated at home is currently lacking. Aim The aim of this study was to compare health care utilization and costs during the first 3 months after a PE diagnosis in patients who are treated at home versus those who are initially hospitalized. Methods Patient-level data of the YEARS cohort study, including 383 normotensive patients diagnosed with PE, were used to estimate the proportion of patients treated at home, mean hospitalization duration in those who were hospitalized, and rates of PE-related readmissions and complications. To correct for baseline differences within the two groups, regression analyses was performed. The primary outcome was the average total health care costs during a 3-month follow-up period for patients initially treated at home or in hospital. Results Mean hospitalization duration for the initial treatment was 0.69 days for those treated initially at home (n = 181) and 4.3 days for those initially treated in hospital (n = 202). Total average costs per hospitalized patient were €3,209 and €1,512 per patient treated at home. The adjusted mean difference was €1,483 (95% confidence interval: €1,181–1,784). Conclusion Home treatment of hemodynamically stable patients with acute PE was associated with an estimated net cost reduction of €1,483 per patient. This difference underlines the advantage of triage-based home treatment of these patients.

Published
2021

40. Caging the dragon: Research approach to COVID-19-related thrombosis

Author

Kruip, M.J.H.A., Cannegieter, S.C., Cate, H. ten, Gorp, E.C.M. van, Juffermans, N.P., Klok, F.A., Maas, C., Vonk-Noordegraaf, A., Dutch COVID Thrombosis Coalition S, Hematology, Virology, Interne Geneeskunde, MUMC+: HVC Trombosezorg (8), MUMC+: MA Alg Interne Geneeskunde (9), MUMC+: HVC Pieken Trombose (9), RS: Carim - B04 Clinical thrombosis and Haemostasis, Intensive Care Medicine, and AII - Inflammatory diseases

Subjects
anticoagulants, medicine.medical_specialty, pulmonary embolism, Coronavirus disease 2019 (COVID-19), PULMONARY-EMBOLISM, Deep vein, COAGULATION, ACTIVATED PROTEIN-C, Study Protocol, COVID‐19, QUALITY-OF-LIFE, Medicine, DEEP-VEIN THROMBOSIS, Intensive care medicine, thrombosis, RISK, VENOUS THROMBOEMBOLISM, COMPLICATIONS, lcsh:RC633-647.5, business.industry, Critically ill, COVID-19, lcsh:Diseases of the blood and blood-forming organs, Hematology, Guideline, ARTERIAL, medicine.disease, University hospital, Thrombosis, Pulmonary embolism, Venous thrombosis, medicine.anatomical_structure, INFLUENZA, venous thrombosis, business, severe acute respiratory syndrome coronavirus 2
Abstract

The incidence of venous thrombosis, mostly pulmonary embolism (PE), ranging from local immunothrombosis to central emboli, but also deep vein thrombosis (DVT) in people with coronavirus disease 2019 (COVID-19) is reported to be remarkably high. The relevance of better understanding, predicting, treating, and preventing COVID-19-associated venous thrombosis meets broad support, as can be concluded from the high number of research, review, and guideline papers that have been published on this topic. The Dutch COVID & Thrombosis Coalition (DCTC) is a multidisciplinary team involving a large number of Dutch experts in the broad area of venous thrombosis and hemostasis research, combined with experts on virology, critically ill patients, pulmonary diseases, and community medicine, across all university hospitals and many community hospitals in the Netherlands. Within the consortium, clinical data of at least 5000 admitted COVID-19-infected individuals are available, including substantial collections of biobanked materials in an estimated 3000 people. In addition to considerable experience in preclinical and clinical thrombosis research, the consortium embeds virology-hemostasis research models within unique biosafety facilities to address fundamental questions on the interaction of virus with epithelial and vascular cells, in relation to the coagulation and inflammatory system. The DCTC has initiated a comprehensive research program to answer many of the current questions on the pathophysiology and best anticoagulant treatment of COVID-19-associated thrombotic complications. The research program was funded by grants of the Netherlands Thrombosis Foundation and the Netherlands Organization for Health Research and Development. Here, we summarize the design and main aims of the research program.

Published
2021

41. Current practice patterns of outpatient management of acute pulmonary embolism: A post-hoc analysis of the YEARS study

Author

Hendriks, S.V., Bavalia, R., Bemmel, T. van, Bistervels, I.M., Eijsvogel, M., Faber, L.M., Fogteloo, J., Hofstee, H.M.A., Hulle, T. van der, Sol, A.I. del, Kruip, M.J.H.A., Mairuhu, A.T.A., Middeldorp, S., Nijkeuter, M., Huisman, M.V., Klok, F.A., YEARS Investigators, Graduate School, ACS - Pulmonary hypertension & thrombosis, AR&D - Amsterdam Reproduction & Development, Vascular Medicine, and Hematology

Subjects
medicine.medical_specialty, 030204 cardiovascular system & hematology, Acute pulmonary embolism, 03 medical and health sciences, 0302 clinical medicine, Post-hoc analysis, Outpatients, Medicine, Humans, Adverse effect, Netherlands, business.industry, Incidence (epidemiology), Hazard ratio, Ambulatory care, Hematology, medicine.disease, Pulmonary embolism, Readmissions, Current practice, 030220 oncology & carcinogenesis, Emergency medicine, Acute Disease, Home treatment, business, Outpatient management, Pulmonary Embolism, Daily practice
Abstract

Background: Studies have shown the safety of home treatment of patients with pulmonary embolism (PE) at low risk of adverse events. Management studies focusing on home treatment have suggested that 30% to 55% of acute PE patients could be treated at home, based on the HESTIA criteria, but data from day-to-day clinical practice are largely unavailable. Aim: To determine current practice patterns of home treatment of acute PE in the Netherlands. Method: We performed a post-hoc analysis of the YEARS study. The main outcomes were the proportion of patients who were discharged

Published
2020

43. Editor's Choice – European Society for Vascular Surgery (ESVS) 2021 Clinical Practice Guidelines on the Management of Venous Thrombosis

Author

Kakkos, S.K., Kakkos, S.K., Gohel, M., Baekgaard, N., Bauersachs, R., Bellmunt-Montoya, S., Black, S.A., ten Cate-Hoek, A.J., Elalamy, I., Enzmann, F.K., Geroulakos, G., Gottsater, A., Hunt, B.J., Mansilha, A., Nicolaides, A.N., Sandset, P.M., Stansby, G., de Borst, G.J., Goncalves, F.B., Chakfe, N., Hinchliffe, R., Kolh, P., Koncar, I., Lindholt, J.S., Tulamo, R., Twine, C.P., Vermassen, F., Wanhainen, A., De Maeseneer, M.G., Comerota, A.J., Gloviczki, P., Kruip, M.J.H.A., Monreal, M., Prandoni, P., de Ceniga, M.V., ESVS Guidelines Committee, Kakkos, S.K., Kakkos, S.K., Gohel, M., Baekgaard, N., Bauersachs, R., Bellmunt-Montoya, S., Black, S.A., ten Cate-Hoek, A.J., Elalamy, I., Enzmann, F.K., Geroulakos, G., Gottsater, A., Hunt, B.J., Mansilha, A., Nicolaides, A.N., Sandset, P.M., Stansby, G., de Borst, G.J., Goncalves, F.B., Chakfe, N., Hinchliffe, R., Kolh, P., Koncar, I., Lindholt, J.S., Tulamo, R., Twine, C.P., Vermassen, F., Wanhainen, A., De Maeseneer, M.G., Comerota, A.J., Gloviczki, P., Kruip, M.J.H.A., Monreal, M., Prandoni, P., de Ceniga, M.V., and ESVS Guidelines Committee

Published
2021

46. Desmopressin in moderate hemophilia A patients: a treatment worth considering

Author

Loomans, J.I., Kruip, M.J.H.A., Carcao, M., Jackson, S., Velzen, A.S. van, Peters, M., Santagostino, E., Platokouki, H., Beckers, E., Voorberg, J., Bom, J.G. van der, Fijnvandraat, K., RISE Consortium, Graduate School, ARD - Amsterdam Reproduction and Development, ACS - Amsterdam Cardiovascular Sciences, General Paediatrics, Paediatric Infectious Diseases / Rheumatology / Immunology, Other departments, ACS - Microcirculation, ACS - Pulmonary hypertension & thrombosis, Hematology, MUMC+: MA Hematologie (9), and RS: CARIM - R1.01 - Blood proteins & engineering

Subjects
Adult, medicine.medical_specialty, Adolescent, VONWILLEBRANDS-DISEASE, medicine.medical_treatment, VON-WILLEBRANDS DISEASE, 030204 cardiovascular system & hematology, Hemophilia A, Gastroenterology, Young Adult, 03 medical and health sciences, BLEEDING DISORDERS, 0302 clinical medicine, Predictive Value of Tests, hemic and lymphatic diseases, Internal medicine, von Willebrand Factor, medicine, Humans, Deamino Arginine Vasopressin, Young adult, Child, Desmopressin, INTRANASAL SPRAY, DDAVP, Factor VIII, FACTOR-VIII, TRANSPLANTATION, business.industry, Moderate hemophilia A, Hematology, Middle Aged, MILD, Prognosis, ENDOTHELIAL-CELLS, Transplantation, Treatment Outcome, Editorial, Nasal spray, Predictive value of tests, Mutation, Factor VIII level, business, NASAL SPRAY, hormones, hormone substitutes, and hormone antagonists, 030215 immunology, medicine.drug, Cohort study
Abstract

Desmopressin increases endogenous factor VIII levels in hemophilia A. Large inter-individual variation in the response to desmopressin is observed. Patients with a lower baseline factor VIII activity tend to show a reduced response, therefore, desmopressin is less frequently used in moderate hemophilia A patients (baseline factor VIII activity 1-5 international units/deciliter), even though factor VIII levels may rise substantially in some of them. We aim to describe the response to desmopressin in moderate hemophilia A patients and to identify predictors. We selected data on 169 patients with moderate hemophilia from the multicenter Response to DDAVP In non-severe hemophilia A patients: in Search for dEterminants (RISE) cohort study. Adequate response to desmopressin was defined as a peak factor VIII level ≥ 30, and excellent response as ≥ 50 international units/deciliter after desmopressin administration. We used univariate and multiple linear regression techniques to analyze predictors of the peak factor VIII level. Response was considered adequate in 68 patients (40%), of whom 25 showed excellent response (15%). Intravenous administration, age, pre-desmopressin factor VIII activity and von Willebrand factor antigen, peak von Willebrand factor activity and desmopressin-induced rise in von Willebrand factor antigen were significant predictors of peak factor VIII level and explained 65% of the inter-individual variation. In 40% of moderate hemophilia A patients, desmopressin response was adequate, thus it is important not to with-hold this group of patients from desmopressin responsiveness. Among the six predictors that we identified for desmopressin-induced factor VIII rise, factor VIII activity and desmopressin-induced rise in von Willebrand factor antigen had the strongest effect.

Published
2018
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49. Outcome of intracranial bleeding managed with prothrombin complex concentrate in patients on direct factor Xa inhibitors or vitamin K antagonists

Author

Bavalia, R., Abdoellakhan, R., Beenen, LF, Brekelmans, M.P.A., Olie, R.H., Cate, H. (Hugo) ten, Huisman, M.V. (Menno), Kruip, M.J.H.A. (Marieke), Middeldorp, S. (Saskia), Meijer, K., Hutten, B.A. (Barbara), Coppens, M, Bavalia, R., Abdoellakhan, R., Beenen, LF, Brekelmans, M.P.A., Olie, R.H., Cate, H. (Hugo) ten, Huisman, M.V. (Menno), Kruip, M.J.H.A. (Marieke), Middeldorp, S. (Saskia), Meijer, K., Hutten, B.A. (Barbara), and Coppens, M

Abstract

Intracranial hemorrhage (ICH) is the most feared complication of anticoagulation with a high mortality and morbidity. Before registration of a specific reversal agent for factor Xa inhibitors (FXa-I), international guidelines recommended prothrombin complex concentrate (PCC), which also is the specific reversal agent for vitamin K antagonists (VKA). In two contemporary cohorts, we compared clinical outcomes between patients with FXa-I and VKA related ICH treated with PCC between 2014 and 2018. Primary outcome was effective hemostasis after 24 h, according to the International Society of Thrombosis and Hemostasis definition. Safety outcomes were defined as venous and arterial thromboembolic complications and death within 30 days. Thirty-six patients with FXa-I-ICH and 39 patients with VKA-ICH were available for analysis. Baseline characteristics were comparable between both groups, except for time from start of symptoms to presentation at the hospital. In the FXa-I-ICH cohort, 24 (73%) patients achieved effective hemostasis compared to 23 (62%) patients in the VKA-ICH cohort (crude odds ratio [OR] 1.62 [95%CI 0.59–4.48], adjusted OR 1.45 [95%CI 0.44–4.83]). Eight (24%) patients with FXa-I-ICH deceased compared to 17 (45%) patients with VKA-ICH (crude OR 0.38 [95%CI 0.14–1.24], adjusted OR 0.41 [95%CI 0.12–1.24]). In this observational cohort study, the outcome of ICH managed with PCC was similar in patients with FXa-I-ICH and in patients with VKA-ICH.

Published
2020
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50. Heavy menstrual bleeding on direct factor Xa inhibitors: Rationale and design of the MEDEA study

Author

Hamulyák, E.N. (Eva N.), Wiegers, H.M.G. (Hanke M. G.), Scheres, L.J.J. (Luuk J. J.), Hutten, B.A. (Barbara), de Lange, M.E. (Maria E.), Timmermans, A. (Anne), Westerweel, P.E. (Peter E.), Nijziel, M.R. (Marten), Kruip, M.J.H.A. (Marieke), Wolde, M. (Marije) ten, Ypma, P.F. (Paula), Klok, F.A. (Frederikus), Nieuwenhuizen, L. (Laurens), van Wissen, S., Hovens, M.M.C. (Marcel M. C.), Faber, L.M. (L.), Kamphuisen, P.W. (Pieter W.), Büller, H.R. (Harry), Middeldorp, S. (Saskia), Hamulyák, E.N. (Eva N.), Wiegers, H.M.G. (Hanke M. G.), Scheres, L.J.J. (Luuk J. J.), Hutten, B.A. (Barbara), de Lange, M.E. (Maria E.), Timmermans, A. (Anne), Westerweel, P.E. (Peter E.), Nijziel, M.R. (Marten), Kruip, M.J.H.A. (Marieke), Wolde, M. (Marije) ten, Ypma, P.F. (Paula), Klok, F.A. (Frederikus), Nieuwenhuizen, L. (Laurens), van Wissen, S., Hovens, M.M.C. (Marcel M. C.), Faber, L.M. (L.), Kamphuisen, P.W. (Pieter W.), Büller, H.R. (Harry), and Middeldorp, S. (Saskia)

Abstract

Background: In premenopausal women, treatment with direct oral factor Xa inhibitors is associated with an increased risk of heavy menstrual bleeding (HMB) compared with vitamin K antagonists (VKA). Treatment with the direct oral thrombin inhibitor dabigatran appears to be associated with a reduced risk of HMB compared with VKA. These findings come from small observational studies or post hoc analyses of trials in which HMB was not a primary outcome. Use of tranexamic acid during the menstrual period may be effective in patients with HMB, but prospective data regarding efficacy and safety in patients on anticoagulant treatment are lacking. Rationale and Design: A direct comparison of a factor Xa inhibitor and a thrombin inhibitor with HMB as primary outcome, as well as an evaluation of the effects of adding tranexamic acid in women with anticoagulant-associated HMB is highly relevant for clinical practice. The MEDEA study is a randomized, open-label, pragmatic clinical trial to evaluate management strategies in premenopausal women with HMB associated with factor Xa inhibitor therapy. Outcomes: Women using factor Xa inhibitors with proven HMB, as assessed by a pictorial blood loss assessment chart (PBAC) score of >150, will be randomized to one of three study arms: (i) switch to dabigatran; (ii) continue factor Xa inhibitor with addition of tranexamic acid during the menstrual period; or (iii) continue factor Xa inhibitor without intervention. The primary outcome is the difference in PBAC score before and after randomization. Here, we present the rationale and highlight several unique features in the design of the study.

Published
2020
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