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1. Intravenous immunoglobulin treatment for mild Guillain-Barré syndrome. An international observational study

Author

Verboon, C., Harbo, T., Cornblath, D. R., Hughes, R. A. C., Van Doorn, P. A., Lunn, M. P., Gorson, K. C., Barroso, F., Kuwabara, S., Galassi, G., Lehmann, H. C., Kusunoki, S., Reisin, R. C., Binda, D., Cavaletti, G., Andersen, Jacobs B. C. H., PhD (Aarhus University Hospital, Aarhus, Denmark), Attarian, S., PhD (CHU Timone, Marseille, France), Badrising, U. A., PhD (Leiden University Medical Centre, Leiden, The, Netherlands), Bateman, K., PhD (Groote Schuur Hospital, Cape, Town, South-Africa), Benedetti, L., PhD (Ospedale Sant’ Andrea La Spezia, Spezia, La, Italy), van den Berg, B., MD (Franciscus Gasthuis, Rotterdam, Van den Bergh, P., Luc, PhD (University Clinic St., Leuven, Belgium), Bertorini, T. E., MD (The University of Tennessee Health Science Center (UTHSC), Memphis, USA), Bhavaraju-Sanka, R., MD (University Hospital/ University of Texas Health Science Center, San Antonio Texas, USA), Bianco (Milan University, M., Humanitas Clinicala and Research Institute Milan, Briani, C., MD (University of Padova, Padova, Italy), Bürmann, J., MD (Universitätsklinikum des Saarlandes, Homburg, Germany), Casasnovas, C., Ciberer, PhD (Bellvitge University Hospital - IDIBELL Neurometabolic Diseases Group., Barcelona, Spain), Chao, C. C., PhD (National Taiwan University Hospital, Taipei, Taiwan), Chavada, G., PhD (Glasgow University, Glasgow, UK), Claeys, K. G., University Hospitals Leuven, PhD (1., Leuven, Belgium, KU Leuven, 2., Cosgrove, J. S., MD (Leeds General Infirmary, Leeds, UK), Dalakas, M. C., Thomas Jefferson University, MD (1., Philadelphia, Usa, National and Kapodistrian University of Athens, 2., Athens, Greece), Davidson, A., MD (University of Glasgow, van Dijk, G. W., MD (Canisius Wilhelmina Hospital, Nijmegen, Dardiotis, E., MD (University of Thessaly, Hospital of Larissa, Larissa, Greece), Derejko, M., MD (Odense University Hospital, Odense, Denmark), Dimachkie, M. M., MD (University of Kansas Medical Center, Kansas, City, Dornonville de la Cour, C., MD (National Hospital Copenhagen, Copenhagen, Denmark), Echaniz-Laguna, A., MD (Bicêtre University Hospital, Paris, France), Eftimov, F., PhD (Amsterdam University Medical Centre, Amsterdam, Faber, C. G., PhD (Maastricht University Medical Centre, Maastricht, Fazio, R., MD (Scientific Institute San Raffaele, Milan, Italy), Fulgenzi, J. Fehmi (University of Oxford E. A., MD (Hospital Cesar Milstein Buenos Aires, Buenos, Aires, Argentina), García-Sobrino, T., MD (Hospital Clínico de Santiago, Santiago de Compostela (A Coruña), Spain), Gijsbers, C. J., MD (Vlietland Hospital, Schiedam, Granit, V., MD (Montefiore Medical, Center, New, York, Grisanti, S., MD (Ospedale Sant’ Andrea La Spezia, Gutiérrez-Gutiérrez, G., MD (Hospital Universitario Infanta Sofia, San, Sebastian, Holbech, J. V., PhD (Odense University Hospital, Holt, J. K. L., Phd, FRCP (The Walton Centre, Liverpool, UK), Homedes, C., Ciberer, MD (Bellvitge University Hospital - IDIBELL Neurometabolic Diseases Group., Islam, B., PhD (International Centre for Diarrhoeal Disease Research, Bangladesh, (icddr, Dhaka, b), Bangladesh), Islam, Z., Jahan, I., PhD candidate (International Centre for Diarrhoeal Disease Research, Jericó Pascual, I., PhD (Complejo Hospitalario de Navarra, Pamplona, Spain), Karafiath, S., MD (University of Utah School of Medicine, Salt Lake City, Kerkhoff, H., PhD (Albert Schweitzer Hospital, Dordrecht, Kimpinski, K., MD (University Hospital, Lhsc, London-Ontario, Canada), Kohler, A., MD (Instituto de Investigaciones Neurológicas Raúl Carrea, Fleni, Kolb, N., MD (University of Vermont, Burlington, Vt, Kuitwaard, K., Albert Schweitzer Hospital, PhD (1., Erasmus MC, 2., Kuwahara, M., PhD (Kindai University, Osaka, Japan), Ladha, S. S., MD (Barrow Neurology Clinics, Phoenix, Arizona, Lee Pan, E., MBChB (Groote Schuur Hospital, Marfia, G. A., MD (Neurological Clinic, Policlinico Tor Vergata, Rome, Italy), Magot, A., MD (Reference Centre for NMD, Nantes University Hospital, France), Márquez Infante, C., MD (Hospital Universitario Virgen del Rocio, Seville, Spain), Martín-Aguilar, L., MD (Hospital de la Santa Creu, i Sant Pau, Universitat Autònoma de Barcelona, Martinez Hernandez, E., MD (Institut d’Investigacions Biomèdiques August Pi, i Sunyer (IDIBAPS), Hospital, Clinic, Mataluni, G., PhD (Neurological Clinic, Meekins, G., MD (University of Minnesota, Miller, J. A. L., PhD (Royal Victoria Infirmary, Newcastle, UK), Monges, M. S., Garrahan, MD (Hospital de Pediatría J. P., Nobile Orazio, E., PhD (Milan University, Pardal, A., MD (Hospital Britanico, Pardo Fernandez (Hospital Clínico de Santiago, J., Péréon, Y., PhD (Reference Centre for NMD, Pulley, M., MD (University of Florida, Jacksonville, USA), Querol Gutierrez, L., PhD (Hospital de la Santa Creu, i Sant Pau, Reddel, S. W., PhD (Concord Repatriation General Hospital, Sydney, Australia), van der Ree, T., (Westfriesgasthuis, Md, Hoorn, Rinaldi, S., Mbchb, Samijn, PhD (University of Oxford J. P. A., MD (Maasstad Hospital, Samukawa, M., Santoro, L., PhD (University Federico II, Napels, Italy), Savransky, A., Garrahan, PhD (Hospital de Pediatría J. P., Schwindling, L., Sedano Tous, M. J., MD (Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Sekiguchi, Y., PhD (Chiba University, Chiba, Japan), Shahrizaila, N., MD (Neurology Unit, Department of Medicine, Faculty of Medicine, University of Malaya, Malaya), Silvestri, N. J., Sindrup, MD (Buffalo Jacobs School of Medicine S., Sommer, C. L., MD (Universitätsklinikum Würzburg, Würzburg, Germany), Spyropoulos (Royal Victoria Infirmary, A., Stein, B., Joseph’s Regional Medical Center, MD (St., Paterson, USA), Tan, C. Y., MRCP (Neurology Unit, Tankisi, H., Vermeij, F., Vytopil, M. V., Wirtz, PhD (Tufts University School of Medicine Lahey Hospital P. W., Phd, (HagaZiekenhuis, The, Hague, Waheed, W., MD (University of Vermont Medical Center, Burlington, Addington, USA). Other collaborators were:J. M., MD (University of Virginia, Charlottesville, USA), Ajroud-Driss, S., MD (Northwestern University Feinberg, Chicago, USA), Antonini, G., MD (Mental Health and Sensory Organs (NESMOS), Sapienza, University, Sant’Andrea, Hospital, Bella, I. R., MD (University of Mass Medical School, Worcester, USA), Brannagan, T. H., MD (Columbia University, New York City, Bunschoten, C., PhD candidate (Erasmus University Medical Centre, Busby, M., Bradford, UK), Butterworth, S., MD (Pinderfields Hospital, Wakefield, UK), Conti, M. E., MD (University Hospital Clinicas, Chen, S., Phd, (Rutgers, Robert Wood Johnson University Hospital, New, Brunswick, Doets, A., Feasby, T. E., MD (University of Calgary, Calgary, Canada), Fokke, C., MD (Gelre Hospital, Zutphen and Apeldoorn, Fujioka, T., MD (Toho University Medical Center, Tokyo, Japan), Garssen, M. P. J., PhD (Jeroen Bosch Hospital, Hertogenbosch, ’S, Gilchrist, J. M., MD (Soulthern Illinois University School of Medicine, Springfield, USA), Gilhuis, J., PhD (Reinier de Graaf Gasthuis, Delft, Goldstein, J. M., MD (Yale University School of Medicine, New, Haven, Goyal, N. A., MD (University of California, Irvine, USA), Hadden, R. D. M., PhD (King’s College Hospital, London, UK), Hsieh, S. T., Htut, M., George’s Hospital, MD (St., Illa, I., Jellema, K., PhD (Haaglanden Medisch Centrum, Kaida, K., PhD (National Defense Medical College, Saitama, Japan), Katzberg, H. D., MD (University of Toronto, Toronto, Canada), Kiers, L., MD (University of Melbourne, Royal Melbourne Hospital, Parkville, Australia), Kokubun, N., MD (Dokkyo Medical University, Tochigi, Japan), van Koningsveld, R., PhD (Elkerliek Hospital, Helmond and Deurne, van der Kooi, A. J., Kwan, J. Y., MD (University of Maryland School of Medicine, Baltimore, USA), Landschoff Lassen, L., MD (Glostrup Hospital, Glostrup, Denmark), Lawson, V., MD (Wexner Medical Center at The Ohio State University, Columbus, USA), Leonhard, S. E., Mandarakas, M., PhD (Erasmus University Medical Centre, Manji, H., FRCP (Ipswich Hospital, Ipswich, UK), Mattiazzi, M. G., MD (Hospital Militar Central, Mcdermott, C. J., MD (Royal Hallamshire Hospital, Nihr, Clinical, Sheffield, UK), Mohammad, Q. D., PhD (National Institute of Neurosciences and Hospital, Dhaka, Bangladesh), Morís de la Tassa, G., MD (Hospital UniversitarioCentral de Asturias, Asturias, Spain), Nascimbene, C., PhD (Luigi Sacco Hospital, Niks, E. H., Nowak, R. J., Osei-Bonsu, M., PhD (James Cook University Hospital, Middlesbrough, UK), Pascuzzi, R. M., MD (University of Indiana School of Medicine, Indianapolis, USA), Roberts, R. C., MD (Addenbrooke’s Hospital Cambridge, Cambridge, UK), Rojas-Marcos, I., MD (Hospital Univesitario Reina Sofia, Cordoba, Spain), Roodbol, J., Rudnicki, S. A., MD (University of Arkansas, Fayetteville, USA), Sachs, G. M., MD (University of Rhode Island, Providence, USA), Schenone, A., Department of Neurosciences, PhD (1., Rehabilitation, Ophthalmology, Genetics and Maternal and Infantile Sciences (DINOGMI), University of Genova, Genova, IRCCS Policlinico San Martino, Italy 2., Genova, Italy), Sheikh, K., PhD (The University of Texas Health Science Center at Houston, Houston, USA), Twydell, P., DO (Spectrum Health System, Grand, Rapids, Van Damme, P., PhD (University Hospital Leuven, Varrato, J. D., DO (Lehigh Valley Health Network, Allentown, USA), Visser, L. H., PhD (Elisabeth-TweeSteden Hospital, Tilburg and Waalwijk, Willison, H. J., PhD (University of Glasgow, van Woerkom (Erasmus MC, M., Zhou, L., PhD (Icahn School, Verboon, C, Harbo, T, Cornblath, D, Hughes, R, Van Doorn, P, Lunn, M, Gorson, K, Barroso, F, Kuwabara, S, Galassi, G, Lehmann, H, Kusunoki, S, Reisin, R, Binda, D, Cavaletti, G, Jacobs, B, consortium, IGOS, consortium, GOS, Neurosurgery, Neurology, and Immunology

Subjects
Adult, Male, medicine.medical_specialty, intravenous immunoglobulins, DIAGNOSIS, Guillain-Barre Syndrome, Settore MED/26, DISEASE, Disease course, Disability Evaluation, 03 medical and health sciences, 0302 clinical medicine, SDG 3 - Good Health and Well-being, hemic and lymphatic diseases, Internal medicine, Clinical endpoint, medicine, Humans, In patient, guillain-barré syndrome, 030212 general & internal medicine, NEUROPATHIES, biology, Guillain-Barre syndrome, business.industry, Guillain-Barré syndrome (GBS), treatment, course, Confounding, Immunoglobulins, Intravenous, Middle Aged, medicine.disease, Confidence interval, Psychiatry and Mental health, Treatment Outcome, biology.protein, Female, Surgery, Observational study, Neurology (clinical), Antibody, business, 030217 neurology & neurosurgery
Abstract

ObjectiveTo compare the disease course in patients with mild Guillain-Barré syndrome (GBS) who were treated with intravenous immunoglobulin (IVIg) or supportive care only.MethodsWe selected patients from the prospective observational International GBS Outcome Study (IGOS) who were able to walk independently at study entry (mild GBS), treated with one IVIg course or supportive care. The primary endpoint was the GBS disability score four weeks after study entry, assessed by multivariable ordinal regression analysis.ResultsOf 188 eligible patients, 148 (79%) were treated with IVIg and 40 (21%) with supportive care. The IVIg group was more disabled at baseline. IVIg treatment was not associated with lower GBS disability scores at 4 weeks (adjusted OR (aOR) 1.62, 95% CI 0.63 to 4.13). Nearly all secondary endpoints showed no benefit from IVIg, although the time to regain full muscle strength was shorter (28 vs 56 days, p=0.03) and reported pain at 26 weeks was lower (n=26/121, 22% vs n=12/30, 40%, p=0.04) in the IVIg treated patients. In the subanalysis with persistent mild GBS in the first 2 weeks, the aOR for a lower GBS disability score at 4 weeks was 2.32 (95% CI 0.76 to 7.13). At 1 year, 40% of all patients had residual symptoms.ConclusionIn patients with mild GBS, one course of IVIg did not improve the overall disease course. The certainty of this conclusion is limited by confounding factors, selection bias and wide confidence limits. Residual symptoms were often present after one year, indicating the need for better treatments in mild GBS.

Published
2021
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2. Predicting the presence of macrovascular causes in non-traumatic intracerebral haemorrhage: the DIAGRAM prediction score

Author

Hilkens, Nina A., van Asch, Charlotte J. J., Werring, David J., Wilson, Duncan, Rinkel, Gabriël J. E., Algra, Ale, Velthuis, Birgitta K., de Kort, G. rard A. P., Witkamp, Theo D., van Nieuwenhuizen, Koen M., de Leeuw, Frank-Erik, Schonewille, Wouter J., de Kort, Paul L. M., Dippel, Diederik W. J., Raaymakers, Theodora W. M., Hofmeijer, Jeannette, Wermer, Marieke J. H., Kerkhoff, Henk, Jellema, Korné, Bronner, Irene M., Remmers, Michel J. M., Bienfait, Henri Paul, Witjes, Ron J. G. M., Jäger, H. Rolf, Greving, Jacoba P., Klijn, Catharina J. M., Boogaarts, H. B., van Dijk, E. J., Schonewille, W. J., Pellikaan, W. M. J., Puppels-de Waard, C., de Kort, P. L. M., Peluso, J. P., van Tuijl, J. H., Hofmeijer, J., Joosten, F. B. M., Dippel, D. W., Khajeh, L., Raaijmakers, T. W. M., Wermer, M. J., van Walderveen, M. A., Kerkhoff, H., Zock, E., Jellema, K., Lycklama, G. J., Bronner, I. M., Remmers, M. J. M., Witjes, R. J. G. M., Bienfait, H. P., Droogh-Greve, K. E., Donders, R. C. J. M., Kwa, V. I. H., Schreuder, T. H., Franke, C. L., Straver, J. S., Jansen, C., Bakker, S. L. M., Pleiter, C. C., Visser, M. C., van Asch, C. J. J., Velthuis, B. K., Rinkel, G. J. E., van Nieuwenhuizen, K. M., Klijn, C. J. M., Neurology, and Amsterdam Neuroscience - Neurovascular Disorders

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Computed Tomography Angiography, Clinical Neurology, Logistic regression, Magnetic resonance angiography, 03 medical and health sciences, Young Adult, 0302 clinical medicine, All institutes and research themes of the Radboud University Medical Center, Predictive Value of Tests, Risk Factors, Internal medicine, Non traumatic, medicine, Humans, 030212 general & internal medicine, cardiovascular diseases, Prospective Studies, Aged, Cerebral Hemorrhage, Netherlands, Central Nervous System Vascular Malformations, Prediction score, medicine.diagnostic_test, business.industry, Arteriovenous malformation, Digital subtraction angiography, Middle Aged, medicine.disease, Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3], nervous system diseases, Cerebral Angiography, Psychiatry and Mental health, Logistic Models, Cohort, Angiography, Cardiology, Surgery, Female, Neurology (clinical), business, 030217 neurology & neurosurgery, Magnetic Resonance Angiography
Abstract

ObjectiveA substantial part of non-traumatic intracerebral haemorrhages (ICH) arises from a macrovascular cause, but there is little guidance on selection of patients for additional diagnostic work-up. We aimed to develop and externally validate a model for predicting the probability of a macrovascular cause in patients with non-traumatic ICH.MethodsThe DIagnostic AngioGRAphy to find vascular Malformations (DIAGRAM) study (n=298; 69 macrovascular cause; 23%) is a prospective, multicentre study assessing yield and accuracy of CT angiography (CTA), MRI/ magnetic resonance angiography (MRA) and intra-arterial catheter angiography in diagnosing macrovascular causes in patients with non-traumatic ICH. We considered prespecified patient and ICH characteristics in multivariable logistic regression analyses as predictors for a macrovascular cause. We combined independent predictors in a model, which we validated in an external cohort of 173 patients with ICH (78 macrovascular cause, 45%).ResultsIndependent predictors were younger age, lobar or posterior fossa (vs deep) location of ICH, and absence of small vessel disease (SVD). A model that combined these predictors showed good performance in the development data (c-statistic 0.83; 95% CI 0.78 to 0.88) and moderate performance in external validation (c-statistic 0.66; 95% CI 0.58 to 0.74). When CTA results were added, the c-statistic was excellent (0.91; 95% CI 0.88 to 0.94) and good after external validation (0.88; 95% CI 0.83 to 0.94). Predicted probabilities varied from 1% in patients aged 51–70 years with deep ICH and SVD, to more than 50% in patients aged 18–50 years with lobar or posterior fossa ICH without SVD.ConclusionThe DIAGRAM scores help to predict the probability of a macrovascular cause in patients with non-traumatic ICH based on age, ICH location, SVD and CTA.

Published
2017
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3. Hyperglycemia predicts poststroke infections in acute ischemic stroke

Author

Zonneveld, Thomas P., Nederkoorn, Paul J., Westendorp, Willeke F., Brouwer, Matthijs C., van de Beek, Diederik, Kruyt, Nyika D., Vermeij, J.-D., Zock, E., Hooijenga, I. J., Kerkhoff, H., Kleyweg, R. P., Kwa, V. I. H., Bosboom, J. L. W., Weisfelt, M., Remmers, M. J. M., van Dijk, E. J., Vermeij, F. H., Schreuder, A. H. C. M. L., Vermeer, S. E., ten Houten, R., Dippel, D. W. J., Kappelle, L. J., van der Worp, H. B., Merkies, I. S. J., de Bruijn, S. F. T. M., de Laat, K. F., Jellema, K., Keizer, K., de Rijk, M. C., Vermeij, A. J., Visser, M. C., Aerden, L. A. M., Schut, E. S., Reichman, L. J. A., de Gans, K., van den Berg-Vos, R. M., van Goor, M. P. J., Wijnhoud, A. D., van der Ree, T. C., Janmaat, M., van Orshoven, N. P., Manschot, S. M., Graduate School, Neurology, ACS - Amsterdam Cardiovascular Sciences, AII - Infectious diseases, ANS - Neuroinfection & -inflammation, AII - Amsterdam institute for Infection and Immunity, Other departments, and ACS - Atherosclerosis & ischemic syndromes

Subjects
Blood Glucose, Male, medicine.medical_specialty, Infections, law.invention, Brain Ischemia, Brain ischemia, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Modified Rankin Scale, Predictive Value of Tests, Diabetes mellitus, Internal medicine, Odds Ratio, Medicine, Humans, 030212 general & internal medicine, Stroke, Aged, Aged, 80 and over, Infection Control, Chi-Square Distribution, business.industry, Ceftriaxone, Odds ratio, Middle Aged, medicine.disease, Anti-Bacterial Agents, Predictive value of tests, Hyperglycemia, Physical therapy, Female, Neurology (clinical), business, Chi-squared distribution, 030217 neurology & neurosurgery
Abstract

Objective:To investigate whether admission hyperglycemia predicts poststroke infections and, if so, whether poststroke infections modify the effect of admission hyperglycemia on functional outcome in ischemic stroke.Methods:We used data from acute ischemic stroke patients in the Preventive Antibiotics in Stroke Study (PASS), a multicenter randomized controlled trial (n = 2,550) investigating the effect of preventive antibiotics on functional outcome. Admission hyperglycemia was defined as blood glucose ≥7.8 mmol/L and poststroke infection as any infection during admission judged by an expert adjudication committee. Functional outcome at 3 months was assessed with the modified Rankin Scale.Results:Of 1,676 nondiabetic ischemic stroke patients, 338 (20%) had admission hyperglycemia. After adjustment for potential confounding variables, admission hyperglycemia was associated with poststroke infection (adjusted odds ratio [aOR] 2.31, 95% CI 1.31–4.07), worse 3-month functional outcome (common aOR 1.40, 95% CI 1.12–1.73), and 3-month mortality (aOR 2.11, 95% CI 1.40–3.19). Additional adjustment for poststroke infection in the functional outcome analysis, done to assess poststroke infection as an intermediate in the pathway from admission hyperglycemia to functional outcome, did not substantially change the model. In patients with recorded diabetes mellitus (n = 418), admission hyperglycemia was not associated with poststroke infection (aOR 0.49, 95% CI 0.15–1.58).Conclusions:In nondiabetic acute ischemic stroke patients, admission hyperglycemia is associated with poststroke infection and worse functional outcome. Poststroke infections did not modify the effect of admission hyperglycemia on functional outcome in ischemic stroke.

Published
2016

4. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial

Author

Westendorp, W.F., Vermeij, J.D., Zock, E., Hooijenga, I.J., Kruyt, N.D., Bosboom, H.J.L.W., Kwa, V.I.H., Weisfelt, M., Remmers, M.J.M., Houten, R. ten, Schreuder, A.H.C.M., Vermeer, S.E., Dijk, E.J. van, Dippel, D.W.J., Dijkgraaf, M.G.W., Spanjaard, L., Vermeulen, M., Poll, T. van der, Prins, J.M., Vermeij, F.H., Roos, Y.B.W.E.M., Kleyweg, R.P., Kerkhoff, H., Brouwer, M.C., Zwinderman, A.H., Beek, D. van de, Nederkoorn, P.J., PASS Investigators, Erasmus MC other, Neurology, Anesthesiology, Neurosciences, Graduate School, Other departments, Clinical Research Unit, AII - Amsterdam institute for Infection and Immunity, Medical Microbiology and Infection Prevention, ANS - Amsterdam Neuroscience, Infectious diseases, Center of Experimental and Molecular Medicine, ACS - Amsterdam Cardiovascular Sciences, APH - Amsterdam Public Health, and Epidemiology and Data Science

Subjects
Male, medicine.medical_specialty, THERAPY, Modified Rankin Scale, Internal medicine, INFECTION, Clinical endpoint, medicine, Humans, Prospective Studies, ACUTE ISCHEMIC-STROKE, Prospective cohort study, Stroke, Aged, Netherlands, Aged, 80 and over, OUTCOMES, Intention-to-treat analysis, business.industry, Standard treatment, Ceftriaxone, MINOCYCLINE, General Medicine, Pneumonia, Recovery of Function, Length of Stay, Middle Aged, CARE, medicine.disease, Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3], Anti-Bacterial Agents, Intention to Treat Analysis, Clinical trial, Treatment Outcome, Urinary Tract Infections, Physical therapy, UPDATE, Female, Quality-Adjusted Life Years, business, medicine.drug, Follow-Up Studies
Abstract

Item does not contain fulltext BACKGROUND: In adults with acute stroke, infections occur commonly and are associated with an unfavourable functional outcome. In the Preventive Antibiotics in Stroke Study (PASS) we aimed to establish whether or not preventive antimicrobial therapy with a third-generation cephalosporin, ceftriaxone, improves functional outcome in patients with acute stroke. METHODS: In this multicentre, randomised, open-label trial with masked endpoint assessment, patients with acute stroke were randomly assigned to intravenous ceftriaxone at a dose of 2 g, given every 24 h intravenously for 4 days, in addition to stroke unit care, or standard stroke unit care without preventive antimicrobial therapy; assignments were made within 24 h after symptom onset. The primary endpoint was functional outcome at 3 months, defined according to the modified Rankin Scale and analysed by intention to treat. The primary analysis was by ordinal regression of the primary outcome. Secondary outcomes included death, infection rates, antimicrobial use, and length of hospital stay. Participants and caregivers were aware of treatment allocation but assessors of outcome were masked to group assignment. This trial is registered with controlled-trials.com, number ISRCTN66140176. FINDINGS: Between July 6, 2010, and March 23, 2014, a total of 2550 patients from 30 sites in the Netherlands, including academic and non-academic medical centres, were randomly assigned to the two treatment groups: 1275 patients to ceftriaxone and 1275 patients to standard treatment (control group). 12 patients (seven in the ceftriaxone group and five in the control group) withdrew consent immediately after randomisation, leaving 2538 patients available for the intention-to-treat-analysis (1268 in the ceftriaxone group and 1270 in the control group). 2514 (99%) of 2538 patients (1257 in each group) completed 3-month follow-up. Preventive ceftriaxone did not affect the distribution of functional outcome scores on the modified Rankin Scale at 3 months (adjusted common odds ratio 0.95 [95% CI 0.82-1.09], p=0.46). Preventive ceftriaxone did not result in an increased occurrence of adverse events. Overgrowth infection with Clostridium difficile occurred in two patients (

Published
2015

5. Early administration of aspirin in patients treated with alteplase for acute ischaemic stroke: a randomised controlled trial

Author

Zinkstok, Sanne M., Roos, Yvo B., Aerden, L. A. M., van den Berg-Vos, R. M., Bakker, S. L. M., Bienfait, H. M. E., Bienfait, H. P., Boon, A. E., Brans, J. W. M., Bronner, I. M., de Bruijn, S. F. T. M., Franke, C. L., Hofstee, D. J., Jansen, B. P. W., Jellema, K., Kalkers, N. F., Portegies, P., Keizer, K., Kerkhoff, H., de Gans, K., Kloos, L. M. H., Kok, A. J. M., de Kort, P. L. M., de Kruijk, J. R., van der Kruijk, R. A., Kwa, V. I. H., Kruyt, N. D., Meijer, R. J., van der Meulen, W. D. M., Mulleners, W. M., Nederkoorn, P. J., van der Ree, T. C., Rooyer, F. A., Saxena, R., Schuiling, W. J., Verbiest, H. B. C., Verhey, J. C. B., Vermeer, S. E., Visée, H. F., Visser, M. C., van der Wiel, H. L., van der Worp, H. B., de Haan, R. J., Stam, J., Vermeulen, M., Peters, R. J. G., Majoie, C. B. L. M., Beenen, L. F., Marquering, H. A., van Geloven, N., Epidemiologie, MUMC+: KIO Kemta (9), RS: CAPHRI School for Public Health and Primary Care, Neurology, ACS - Amsterdam Cardiovascular Sciences, ANS - Amsterdam Neuroscience, Other departments, APH - Amsterdam Public Health, Clinical Research Unit, Cardiology, Radiology and Nuclear Medicine, Other Research, and Biomedical Engineering and Physics

Subjects
Male, medicine.medical_specialty, Time Factors, Drug Administration Schedule, law.invention, Fibrinolytic Agents, Randomized controlled trial, Modified Rankin Scale, law, Internal medicine, Secondary Prevention, medicine, Clinical endpoint, Humans, Prospective Studies, Platelet activation, Infusions, Intravenous, Stroke, Aged, Aged, 80 and over, Aspirin, business.industry, Standard treatment, General Medicine, Middle Aged, medicine.disease, Surgery, Treatment Outcome, Tissue Plasminogen Activator, Early Termination of Clinical Trials, Platelet aggregation inhibitor, Drug Therapy, Combination, Female, business, Intracranial Hemorrhages, Platelet Aggregation Inhibitors, medicine.drug
Abstract

Summary Background Thrombolysis with intravenous alteplase is the only approved treatment for acute ischaemic stroke. After alteplase-induced recanalisation, reocclusion occurs in 14–34% of patients, probably because of platelet activation. Early administration of antiplatelet therapy after alteplase could reduce the risk of reocclusion and improve outcome. We compared the effects of early addition of intravenous aspirin to alteplase with standard alteplase without aspirin. Methods In this multicentre, randomised, open-label trial with blind-endpoint assessment, patients with acute ischaemic stroke treated with alteplase were randomly assigned to 300 mg intravenous aspirin within 90 min after start of alteplase treatment or to no additional treatment. In both groups, oral antiplatelet therapy was started 24 h after alteplase treatment. The primary endpoint was favourable outcome, defined as a score of 0–2 on the modified Rankin scale at 3 months. This trial is registered with the Netherlands Trial Register (NTR822). Findings Between July 29, 2008, and April 20, 2011, 642 patients (322 patients aspirin, 320 patients standard treatment) of the targeted 800 patients were enrolled. At that time, the trial was terminated prematurely because of an excess of symptomatic intracranial haemorrhage (SICH) and no evidence of benefit in the aspirin group. At 3 months, 174 (54·0%) patients in the aspirin group versus 183 (57·2%) patients in the standard treatment group had a favourable outcome (absolute difference −3·2%, 95% CI −10·8 to 4·2; crude relative risk 0·94, 0·82 to 1·09, p=0·42). Adjusted odds ratio was 0·91 (95% CI 0·66–1·26, p=0·58). SICH occurred more often in the aspirin group (14 [4·3%] patients) than in the standard treatment group (five [1·6%]; absolute difference 2·8%, 95% CI 0·2–5·4; p=0·04). SICH was more often the cause of poor outcome in the aspirin group compared with the standard treatment group (11 vs 1, p=0·006). Interpretation Early administration of intravenous aspirin in patients with acute ischaemic stroke treated with alteplase does not improve outcome at 3 months and increases the risk of SICH. The results of this trial do not support a change of the current guidelines, which advise to start antiplatelet therapy 24 h after alteplase. Funding The Dutch Heart Foundation.

Published
2012

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