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1. Ultra-Early and Short-Term Tranexamic Acid Treatment in Patients With Good- and Poor-Grade Aneurysmal Subarachnoid Hemorrhage

Author

Neurologen, Brain, Circulatory Health, Projectafdeling CVZ, Tjerkstra, Maud A., Post, René, Germans, Menno R., Vergouwen, Mervyn D.I., Jellema, Korne, Koot, Radboud W., Kruyt, Nyika D., Wolfs, Jasper F.C., De Beer, Frits C., Kieft, Hans H., Nanda, Dharmin, Van Der Pol, Bram, Roks, Gerwin, De Beer, Frank, Reichman, Loes J.A., Brouwers, Paul J.A.M., Kwa, Vincent I.H., Van Der Ree, Taco C., Bienfait, Henri P., Boogaarts, Hieronymus D., Klijn, Catharina J., Visser, Victoria, van den Berg, René, Coert, Bert A., Horn, Janneke, Majoie, Charles B.L.M., Rinkel, Gabriël J.E., Roos, Yvo B.W.E.M., Vandertop, W. Peter, Verbaan, Dagmar, ULTRA trial study group, Neurologen, Brain, Circulatory Health, Projectafdeling CVZ, Tjerkstra, Maud A., Post, René, Germans, Menno R., Vergouwen, Mervyn D.I., Jellema, Korne, Koot, Radboud W., Kruyt, Nyika D., Wolfs, Jasper F.C., De Beer, Frits C., Kieft, Hans H., Nanda, Dharmin, Van Der Pol, Bram, Roks, Gerwin, De Beer, Frank, Reichman, Loes J.A., Brouwers, Paul J.A.M., Kwa, Vincent I.H., Van Der Ree, Taco C., Bienfait, Henri P., Boogaarts, Hieronymus D., Klijn, Catharina J., Visser, Victoria, van den Berg, René, Coert, Bert A., Horn, Janneke, Majoie, Charles B.L.M., Rinkel, Gabriël J.E., Roos, Yvo B.W.E.M., Vandertop, W. Peter, Verbaan, Dagmar, and ULTRA trial study group

Published
2024

2. Impact of time to start of tranexamic acid treatment on rebleed risk and outcome in aneurysmal subarachnoid hemorrhage

Author

Neurologen, Brain, Circulatory Health, UMC Utrecht, Germans, Menno R., Tjerkstra, Maud A., Post, René, Brenner, Amy, Vergouwen, Mervyn D.I., Rinkel, Gabriël J.E., Roos, Yvo B.W.E.M., van den Berg, René, Coert, Bert A., Vandertop, W. Peter, Verbaan, Dagmar, Neurologen, Brain, Circulatory Health, UMC Utrecht, Germans, Menno R., Tjerkstra, Maud A., Post, René, Brenner, Amy, Vergouwen, Mervyn D.I., Rinkel, Gabriël J.E., Roos, Yvo B.W.E.M., van den Berg, René, Coert, Bert A., Vandertop, W. Peter, and Verbaan, Dagmar

Published
2024

3. Impact of time to start of tranexamic acid treatment on rebleed risk and outcome in aneurysmal subarachnoid hemorrhage

Author

Germans, Menno R; https://orcid.org/0000-0003-2185-4526, Tjerkstra, Maud A; https://orcid.org/0000-0001-9060-3435, Post, René; https://orcid.org/0000-0001-7844-6262, Brenner, Amy, Vergouwen, Mervyn DI; https://orcid.org/0000-0002-6823-1628, Rinkel, Gabriël Je, Roos, Yvo Bwem; https://orcid.org/0000-0001-9205-5882, van den Berg, René, Coert, Bert A, Vandertop, W Peter; https://orcid.org/0000-0001-5417-0265, Verbaan, Dagmar; https://orcid.org/0000-0002-9212-5470, Germans, Menno R; https://orcid.org/0000-0003-2185-4526, Tjerkstra, Maud A; https://orcid.org/0000-0001-9060-3435, Post, René; https://orcid.org/0000-0001-7844-6262, Brenner, Amy, Vergouwen, Mervyn DI; https://orcid.org/0000-0002-6823-1628, Rinkel, Gabriël Je, Roos, Yvo Bwem; https://orcid.org/0000-0001-9205-5882, van den Berg, René, Coert, Bert A, Vandertop, W Peter; https://orcid.org/0000-0001-5417-0265, and Verbaan, Dagmar; https://orcid.org/0000-0002-9212-5470

Abstract

INTRODUCTION: The ULTRA-trial investigated effectiveness of ultra-early administration of tranexamic acid (TXA) in subarachnoid hemorrhage (SAH) and showed that TXA reduces the risk of rebleeding without concurrent improvement in clinical outcome. Previous trials in bleeding conditions, distinct from SAH, have shown that time to start of antifibrinolytic treatment influences outcome. This post-hoc analysis of the ULTRA-trial investigates whether the interval between hemorrhage and start of TXA impacts the effect of TXA on rebleeding and functional outcome following aneurysmal SAH. PATIENTS AND METHODS: A post-hoc comparative analysis was conducted between aneurysmal SAH patients of the ULTRA-trial, receiving TXA and usual care to those receiving usual care only. We assessed confounders, hazard ratio (HR) of rebleeding and odds ratio (OR) of good outcome (modified Rankin Scale 0-3) at 6 months, and investigated the impact of time between hemorrhage and start of TXA on the treatment effect, stratified into time categories (0-3, 3-6 and >6 h). RESULTS: Sixty-four of 394 patients (16.2%) in the TXA group experienced a rebleeding, compared to 83 of 413 patients (19.9%) with usual care only (HR 0.86, 95% confidence interval (CI): 0.62-1.19). Time to start of TXA modifies the effect of TXA on rebleeding rate (p < 0.001), with a clinically non-relevant reduction observed only when TXA was initiated after 6 h (absolute rate reduction 1.4%). Tranexamic acid treatment showed no effect on good outcome (OR 0.96, 95% CI: 0.72-1.27) with no evidence of effect modification on the time to start of TXA (p = 0.53). DISCUSSION AND CONCLUSIONS: This study suggests that the effect of TXA on rebleeding is modified by time to treatment, providing a protective, albeit clinically non-relevant, effect only when started after 6 h. No difference in functional outcome was seen. Routine TXA treatment in the aneurysmal SAH population, even within a specified time frame, is not recommended to impro

Published
2024

4. Ultra-Early and Short-Term Tranexamic Acid Treatment in Patients With Good- and Poor-Grade Aneurysmal Subarachnoid Hemorrhage

Author

Tjerkstra, Maud A; https://orcid.org/0000-0001-9060-3435, Post, René; https://orcid.org/0000-0001-7844-6262, Germans, Menno R; https://orcid.org/0000-0003-2185-4526, Vergouwen, Mervyn D I; https://orcid.org/0000-0002-6823-1628, Jellema, Korne, Koot, Radboud W, Kruyt, Nyika D; https://orcid.org/0000-0002-2320-0932, Wolfs, Jasper F C, De Beer, Frits C; https://orcid.org/0000-0003-4725-7156, Kieft, Hans H; https://orcid.org/0000-0003-2083-710X, Nanda, Dharmin, Van Der Pol, Bram; https://orcid.org/0000-0001-5173-9989, Roks, Gerwin; https://orcid.org/0000-0002-1393-9848, De Beer, Frank, Reichman, Loes J A, Brouwers, Paul J A M, Kwa, Vincent I H; https://orcid.org/0000-0002-0942-6206, Van Der Ree, Taco C, Bienfait, Henri P; https://orcid.org/0000-0002-5698-0031, Boogaarts, Hieronymus D; https://orcid.org/0000-0001-5855-2447, Klijn, Catharina J; https://orcid.org/0000-0002-8495-4578, Visser, Victoria, van den Berg, René, Coert, Bert A, Horn, Janneke; https://orcid.org/0000-0002-3788-7675, Majoie, Charles B L M; https://orcid.org/0000-0002-7600-9568, Rinkel, Gabriël J E, Roos, Yvo B W E M; https://orcid.org/0000-0001-9205-5882, Vandertop, W Peter; https://orcid.org/0000-0001-5417-0265, Verbaan, Dagmar; https://orcid.org/0000-0002-9212-5470, Tjerkstra, Maud A; https://orcid.org/0000-0001-9060-3435, Post, René; https://orcid.org/0000-0001-7844-6262, Germans, Menno R; https://orcid.org/0000-0003-2185-4526, Vergouwen, Mervyn D I; https://orcid.org/0000-0002-6823-1628, Jellema, Korne, Koot, Radboud W, Kruyt, Nyika D; https://orcid.org/0000-0002-2320-0932, Wolfs, Jasper F C, De Beer, Frits C; https://orcid.org/0000-0003-4725-7156, Kieft, Hans H; https://orcid.org/0000-0003-2083-710X, Nanda, Dharmin, Van Der Pol, Bram; https://orcid.org/0000-0001-5173-9989, Roks, Gerwin; https://orcid.org/0000-0002-1393-9848, De Beer, Frank, Reichman, Loes J A, Brouwers, Paul J A M, Kwa, Vincent I H; https://orcid.org/0000-0002-0942-6206, Van Der Ree, Taco C, Bienfait, Henri P; https://orcid.org/0000-0002-5698-0031, Boogaarts, Hieronymus D; https://orcid.org/0000-0001-5855-2447, Klijn, Catharina J; https://orcid.org/0000-0002-8495-4578, Visser, Victoria, van den Berg, René, Coert, Bert A, Horn, Janneke; https://orcid.org/0000-0002-3788-7675, Majoie, Charles B L M; https://orcid.org/0000-0002-7600-9568, Rinkel, Gabriël J E, Roos, Yvo B W E M; https://orcid.org/0000-0001-9205-5882, Vandertop, W Peter; https://orcid.org/0000-0001-5417-0265, and Verbaan, Dagmar; https://orcid.org/0000-0002-9212-5470

Abstract

The results of the ULTRA trial showed that ultra-early and short-term treatment with tranexamic acid (TXA) does not improve clinical outcome after aneurysmal subarachnoid hemorrhage (aSAH). Possibly, the lack of a beneficial effect in all patients with aSAH is masked by antagonistic effects of TXA in certain subgroups. In this post hoc subgroup analysis, we investigated the effect of TXA on clinical outcome in patients with good-grade and poor-grade aSAH.

Published
2024

5. Aneurysm treatment within 6 h versus 6–24 h after rupture in patients with subarachnoid hemorrhage

Author

Neurologen, Brain, Circulatory Health, Vergouwen, Mervyn D.I., Germans, Menno R., Post, René, Tjerkstra, Maud A., Coert, Bert A., Rinkel, Gabriel J.E., Peter Vandertop, William, Verbaan, Dagmar, Neurologen, Brain, Circulatory Health, Vergouwen, Mervyn D.I., Germans, Menno R., Post, René, Tjerkstra, Maud A., Coert, Bert A., Rinkel, Gabriel J.E., Peter Vandertop, William, and Verbaan, Dagmar

Published
2023

6. Clinical response following hypertension induction for clinical delayed cerebral ischemia following subarachnoid hemorrhage: A retrospective, multicenter, cohort study

Author

Neurochirurgen, Neurologen, Brain, Circulatory Health, AIOS Psychiatrie, Tjerkstra, Maud A, Müller, Marcella C A, Coert, Bert A, Hoefnagels, Friso W A, Vergouwen, Mervyn D I, van Vliet, Peter, Ooms, Lizzy, Rinkel, Gabriël J E, Slooter, Arjen J C, Moojen, Wouter A, Jellema, Korné, Vandertop, W Peter, Verbaan, Dagmar, Neurochirurgen, Neurologen, Brain, Circulatory Health, AIOS Psychiatrie, Tjerkstra, Maud A, Müller, Marcella C A, Coert, Bert A, Hoefnagels, Friso W A, Vergouwen, Mervyn D I, van Vliet, Peter, Ooms, Lizzy, Rinkel, Gabriël J E, Slooter, Arjen J C, Moojen, Wouter A, Jellema, Korné, Vandertop, W Peter, and Verbaan, Dagmar

Published
2023

7. Aneurysm treatment within 6 h versus 6-24 h after rupture in patients with subarachnoid hemorrhage

Author

Vergouwen, Mervyn DI; https://orcid.org/0000-0002-6823-1628, Germans, Menno R, Post, René, Tjerkstra, Maud A, Coert, Bert A, Rinkel, Gabriel Je, Peter Vandertop, William, Verbaan, Dagmar, Vergouwen, Mervyn DI; https://orcid.org/0000-0002-6823-1628, Germans, Menno R, Post, René, Tjerkstra, Maud A, Coert, Bert A, Rinkel, Gabriel Je, Peter Vandertop, William, and Verbaan, Dagmar

Abstract

BACKGROUND The risk of rebleeding after aneurysmal subarachnoid hemorrhage (aSAH) is the highest during the initial hours after rupture. Emergency aneurysm treatment may decrease this risk, but is a logistic challenge and economic burden. We aimed to investigate whether aneurysm treatment <6 h after rupture is associated with a decreased risk of poor functional outcome compared to aneurysm treatment 6-24 h after rupture. METHODS We used data of patients included in the ULTRA trial (NCT02684812). All patients in ULTRA were admitted within 24 h after aneurysm rupture. For the current study, we excluded patients in whom the aneurysm was not treated <24 h after rupture. We calculated crude and adjusted risk ratios (aRR) with 95% confidence intervals using Poisson regression analyses for poor functional outcome (death or dependency, assessed by the modified Rankin Scale) after aneurysm treatment <6 h versus 6-24 h after rupture. Adjustments were made for age, sex, clinical condition on admission (WFNS scale), amount of extravasated blood (Fisher score), aneurysm location, tranexamic acid treatment, and aneurysm treatment modality. RESULTS We included 497 patients. Poor outcome occurred in 63/110 (57%) patients treated within 6 h compared to 145/387 (37%) patients treated 6-24 h after rupture (crude RR: 1.53, 95% CI: 1.24-1.88; adjusted RR: 1.36, 95% CI: 1.11-1.66). CONCLUSION Aneurysm treatment <6 h is not associated with better functional outcome than aneurysm treatment 6-24 h after rupture. Our results do not support a strategy aiming to treat every patient with a ruptured aneurysm <6 h after rupture.

Published
2023

8. Laboratory biomarkers of delayed cerebral ischemia following subarachnoid hemorrhage: A systematic review

Author

Tjerkstra, Maud, Labib, Homeyra, Coert, Bert A., Spijker, René, Coutinho, Jonathan M., Vandertop, W. Peter, Verbaan, Dagmar, Tjerkstra, Maud, Labib, Homeyra, Coert, Bert A., Spijker, René, Coutinho, Jonathan M., Vandertop, W. Peter, and Verbaan, Dagmar

Abstract

Delayed cerebral ischemia (DCI) substantially contributes to disability and death in subarachnoid hemorrhage (SAH) patients; however, its pathophysiology is incompletely understood and diagnostic and therapeutic strategies are lacking. Biomarkers may help to elucidate the pathophysiology, optimize early diagnosis, or provide treatment targets. We systematically searched PubMed and Embase on October 13, 2021, for studies that evaluated at least one laboratory biomarker in patients with DCI, using the most up-to-date definition of DCI as proposed by a panel of experts in 2010. Quality of studies was assessed using the Newcastle-Ottawa Scale or Cochrane Collaboration’s risk of bias assessment tool. Biomarkers of clinical and radiological DCI were analyzed separately. Results were meta-analyzed if possible, otherwise narratively reviewed. Biomarkers were classified as significant, inconclusive, or nonsignificant. We defined validated biomarkers as those with significant results in meta-analyses, or in at least two studies using similar methodologies within the same time interval after SAH. The search yielded 209 articles with 724 different biomarkers; 166 studies evaluated 646 biomarkers of clinical DCI, of which 141 were significant and 7 were validated biomarkers (haptoglobulin 2-1 and 2-2, ADAMTS13, vWF, NLR, P-selectin, F2-isoprostane); 78 studies evaluated 165 biomarkers of radiological DCI, of which 63 were significant and 1 was a validated biomarker (LPR). Hence, this review provides a selection of seven biomarkers of clinical DCI and one biomarker of radiological DCI as most promising biomarkers of DCI. Future research should focus on determining the exact predictive, diagnostic, and therapeutic potentials of these biomarkers.

Published
2023

9. Prehemorrhage antiplatelet use in aneurysmal subarachnoid hemorrhage and impact on clinical outcome

Author

Sebök, Martina; https://orcid.org/0000-0002-7246-3421, Hostettler, Isabel C; https://orcid.org/0000-0002-9004-2540, Keller, Emanuela; https://orcid.org/0000-0002-7560-7574, Rautalin, Ilari M; https://orcid.org/0000-0002-6283-0398, Coert, Bert A, Vandertop, William P; https://orcid.org/0000-0001-5417-0265, Post, René; https://orcid.org/0000-0001-7844-6262, Sardeha, Ali, Tjerkstra, Maud A, Regli, Luca, Verbaan, Dagmar, Germans, Menno R; https://orcid.org/0000-0003-2185-4526, Sebök, Martina; https://orcid.org/0000-0002-7246-3421, Hostettler, Isabel C; https://orcid.org/0000-0002-9004-2540, Keller, Emanuela; https://orcid.org/0000-0002-7560-7574, Rautalin, Ilari M; https://orcid.org/0000-0002-6283-0398, Coert, Bert A, Vandertop, William P; https://orcid.org/0000-0001-5417-0265, Post, René; https://orcid.org/0000-0001-7844-6262, Sardeha, Ali, Tjerkstra, Maud A, Regli, Luca, Verbaan, Dagmar, and Germans, Menno R; https://orcid.org/0000-0003-2185-4526

Abstract

BACKGROUND: Literature is inconclusive regarding the association between antiplatelet agents use and outcome after aneurysmal subarachnoid hemorrhage. AIMS: To investigate the association between clinical outcome and prehemorrhage use in aneurysmal subarachnoid hemorrhage patients as well as the impact of thrombocyte transfusion on rebleed and clinical outcome. METHODS: Data were collected from prospective databases of two European tertiary reference centers for aneurysmal subarachnoid hemorrhage patients. Patients were divided into "antiplatelet-user" and "non-user" according to the use of acetylsalicylic acid prior to the hemorrhage. Primary outcome was poor clinical outcome at six months (Glasgow Outcome Scale score 1-3). Secondary outcomes were in-hospital mortality and impact of thrombocyte transfusion. RESULTS: Of the 1033 patients, 161 (15.6%) were antiplatelet users. The antiplatelet users were older with higher incidence of cardiovascular risk factors. Antiplatelet use was associated with poor outcome and in-hospital mortality. After correction for age, sex, World Federation of Neurosurgical Societies score, infarction and heart disorder, pre-hemorrhage acetylsalicylic acid use was only associated with poor clinical outcome at six months (adjusted OR 1.80, 95% CI 1.08-3.02). Thrombocyte transfusion was not associated with a reduction in rebleed or poor clinical outcome. CONCLUSION: In this multicenter study, the prehemorrhage acetylsalicylic acid use in aneurysmal subarachnoid hemorrhage patients was independently associated with poor clinical outcome at six months. Thrombocyte transfusion was not associated with the rebleed rate or poor clinical outcome at six months.

Published
2022

10. Tranexamic Acid After Aneurysmal Subarachnoid Hemorrhage: Post-Hoc Analysis of the ULTRA Trial

Author

Neurologen, Brain, Circulatory Health, Neurochirurgen, Tjerkstra, Maud A, Post, Rene, Germans, Menno R, Vergouwen, Mervyn D I, Jellema, Korné, Koot, Radboud W, Kruyt, Nyika D, Willems, Peter W A, Wolfs, Jasper F C, de Beer, Frits C, Kieft, Hans, Nanda, Dharmin, van der Pol, Bram, Roks, Gerwin, de Beer, Frank, Halkes, Patricia H A, Reichman, Loes J A, Brouwers, Paul J A M, Van den Berg-Vos, Renske M, Kwa, Vincent I H, van der Ree, Taco C, Bronner, Irene, Bienfait, Henri P, Boogaarts, Hieronymus, Klijn, Catharina Jm, van den Berg, René, Coert, Bert A, Horn, Janneke, Majoie, Charles B L M, Rinkel, Gabriël J E, Roos, Yvo B W M, Vandertop, William, Verbaan, Dagmar, Neurologen, Brain, Circulatory Health, Neurochirurgen, Tjerkstra, Maud A, Post, Rene, Germans, Menno R, Vergouwen, Mervyn D I, Jellema, Korné, Koot, Radboud W, Kruyt, Nyika D, Willems, Peter W A, Wolfs, Jasper F C, de Beer, Frits C, Kieft, Hans, Nanda, Dharmin, van der Pol, Bram, Roks, Gerwin, de Beer, Frank, Halkes, Patricia H A, Reichman, Loes J A, Brouwers, Paul J A M, Van den Berg-Vos, Renske M, Kwa, Vincent I H, van der Ree, Taco C, Bronner, Irene, Bienfait, Henri P, Boogaarts, Hieronymus, Klijn, Catharina Jm, van den Berg, René, Coert, Bert A, Horn, Janneke, Majoie, Charles B L M, Rinkel, Gabriël J E, Roos, Yvo B W M, Vandertop, William, and Verbaan, Dagmar

Published
2022

11. Blood pressure and the risk of rebleeding and delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage

Author

Opleiding Neurologie, Neurologen, Brain, Circulatory Health, Cardiovasculaire Epi Team 5, Divisie Vitale Functies, AIOS Psychiatrie, Medische Staf Intensive Care, Biostatistiek Onderzoek, Child Health, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, Gathier, Celine S, Zijlstra, IJsbrand A J, Rinkel, Gabriel J E, Groenhof, T Katrien J, Verbaan, Dagmar, Coert, Bert A, Müller, Marcella C A, van den Bergh, Walter M, Slooter, Arjen J C, Eijkemans, Marinus J C, Opleiding Neurologie, Neurologen, Brain, Circulatory Health, Cardiovasculaire Epi Team 5, Divisie Vitale Functies, AIOS Psychiatrie, Medische Staf Intensive Care, Biostatistiek Onderzoek, Child Health, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, Gathier, Celine S, Zijlstra, IJsbrand A J, Rinkel, Gabriel J E, Groenhof, T Katrien J, Verbaan, Dagmar, Coert, Bert A, Müller, Marcella C A, van den Bergh, Walter M, Slooter, Arjen J C, and Eijkemans, Marinus J C

Published
2022

12. Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage in Young Patients With a History of Migraine

Author

Neurologen, Brain, Circulatory Health, van Os, Hendrikus J A, Verbaan, Dagmar, Ruigrok, Ynte M, Dennesen, Paul, Müller, Marcella C A, Coert, Bert A, Vergouwen, Mervyn D I, Wermer, Marieke J H, Neurologen, Brain, Circulatory Health, van Os, Hendrikus J A, Verbaan, Dagmar, Ruigrok, Ynte M, Dennesen, Paul, Müller, Marcella C A, Coert, Bert A, Vergouwen, Mervyn D I, and Wermer, Marieke J H

Published
2022

13. Deferred Consent in an Acute Stroke Trial from a Patient, Proxy, and Physician Perspective: A Cross-Sectional Survey

Author

Projectafdeling CVZ, Bioethics & Health Humanities, JC onderzoeksprogramma Methodologie, Circulatory Health, Opleiding Neurologie, Neurologen, Brain, Koopman, Inez, Verbaan, Dagmar, Vandertop, W Peter, van der Graaf, Rieke, Kompanje, Erwin J O, Post, René, Coert, Bert A, Ploem, Martine C, Sluis, Wouter M, Scheijmans, Féline E V, Rinkel, Gabriel J E, Vergouwen, Mervyn D I, Projectafdeling CVZ, Bioethics & Health Humanities, JC onderzoeksprogramma Methodologie, Circulatory Health, Opleiding Neurologie, Neurologen, Brain, Koopman, Inez, Verbaan, Dagmar, Vandertop, W Peter, van der Graaf, Rieke, Kompanje, Erwin J O, Post, René, Coert, Bert A, Ploem, Martine C, Sluis, Wouter M, Scheijmans, Féline E V, Rinkel, Gabriel J E, and Vergouwen, Mervyn D I

Published
2022

14. Interventions in Acute Intracranial Surgery: An Evidence-Based Perspective

Author

Post, René; https://orcid.org/0000-0001-7844-6262, Germans, Menno R; https://orcid.org/0000-0003-2185-4526, Buis, Dennis R, Coert, Bert A, Vandertop, W Peter, Verbaan, Dagmar, Post, René; https://orcid.org/0000-0001-7844-6262, Germans, Menno R; https://orcid.org/0000-0003-2185-4526, Buis, Dennis R, Coert, Bert A, Vandertop, W Peter, and Verbaan, Dagmar

Abstract

From a pathophysiological point of view, early neurosurgical treatment seems essential to prevent secondary brain injury and has been stated as the "time-is-brain" concept. However, the question immediately rises: "Is there an optimal time window for acute intracranial neurosurgical interventions?" In neurosurgery, treatment modality has been studied far more extensively than timing to surgery ("time-to-surgery"). The majority of acute intracranial neurosurgical interventions are carried out for traumatic brain injury and hemorrhagic or ischemic stroke. Current guidelines for traumatic brain injury, spontaneous intracerebral hemorrhage, aneurysmal subarachnoid hemorrhage, and middle cerebral artery infarction are reviewed and lessons learned from the randomized controlled trials mentioned are discussed. In acute intracranial neurosurgical interventions, "delayed consent" procedures could play an important role for this field of research. Whether there is an optimal time window for acute intracranial neurosurgical interventions seems difficult to be answered with randomized controlled trials referred to in the current guidelines. Observational designs, such as comparative effectiveness research, and special statistical techniques, may provide a better understanding in the optimal "time-to-surgery."

Published
2022

15. Safety and efficacy of C1-inhibitor in traumatic brain injury (CIAO@TBI):study protocol for a randomized, placebo-controlled, multi-center trial

Author

van Erp, Inge A.M., van Essen, Thomas A., Fluiter, Kees, van Zwet, Erik, van Vliet, Peter, Baas, Frank, Haitsma, Iain, Verbaan, Dagmar, Coert, Bert, de Ruiter, Godard C.W., Moojen, Wouter A., van der Jagt, Mathieu, Peul, Wilco C., van Erp, Inge A.M., van Essen, Thomas A., Fluiter, Kees, van Zwet, Erik, van Vliet, Peter, Baas, Frank, Haitsma, Iain, Verbaan, Dagmar, Coert, Bert, de Ruiter, Godard C.W., Moojen, Wouter A., van der Jagt, Mathieu, and Peul, Wilco C.

Abstract

Background: Traumatic brain injury (TBI) is a major cause of death and disability across all ages. After the primary impact, the pathophysiologic process of secondary brain injury consists of a neuroinflammation response that critically leads to irreversible brain damage in the first days after the trauma. A key catalyst in this inflammatory process is the complement system. Inhibiting the complement system could therefore be a therapeutic target in TBI. Objective: To study the safety and efficacy of C1-inhibitor (C1-INH) compared to placebo in patients with TBI. By temporarily blocking the complement system, we hypothesize a decrease in the posttraumatic neuroinflammatory response resulting in a less unfavorable clinical outcome for TBI patients. Methods: CIAO@TBI is a multicenter, randomized, blinded, phase II placebo-controlled trial. Adult TBI patients with GCS < 13 requiring intracranial pressure (ICP) monitoring will be randomized, using block randomization, within 12 h after trauma to one dose 6000 IU C1-INH or placebo. A total of 106 patients will be included, and follow-up will occur up to 12 months. The primary endpoints are (1) Therapy Intensity Level (TIL) Scale, (2) Glasgow Outcome Scale-Extended (GOSE) at 6 months, and (3) complication rate during hospitalization. Outcomes will be determined by a trial nurse blinded for the treatment allocation. Analyses will be conducted in an intention-to-treat analysis. Discussion: We expect that C1-INH administration will be safe and potentially effective to improve clinical outcomes by reducing neuroinflammation in TBI patients. Trial registration: ClinicalTrials.gov NCT04489160. Registered on 27 July 2020. EudraCT 2020-000140-58.

Published
2021

16. Update of the ULtra-early TRranexamic Acid after subarachnoid hemorrhage (ULTRA) trial: statistical analysis plan

Author

Post, René; https://orcid.org/0000-0001-7844-6262, Germans, Menno R, Coert, Bert A, Rinkel, Gabriël J E, Vandertop, W Peter, Verbaan, Dagmar, Post, René; https://orcid.org/0000-0001-7844-6262, Germans, Menno R, Coert, Bert A, Rinkel, Gabriël J E, Vandertop, W Peter, and Verbaan, Dagmar

Abstract

BACKGROUND: Recurrent bleeding from an intracranial aneurysm after subarachnoid hemorrhage (SAH) is associated with unfavorable outcome. Recurrent bleeding before aneurysm occlusion can be performed occurs in up to one in five patients and most often happens within the first 6 h after the primary hemorrhage. Reducing the rate of recurrent bleeding could be a major factor in improving clinical outcome after SAH. Tranexamic acid (TXA) reduces the risk of recurrent bleeding but has thus far not been shown to improve functional outcome, probably because of a higher risk of delayed cerebral ischemia (DCI). To reduce the risk of ultraearly recurrent bleeding, TXA should be administered as soon as possible after diagnosis and before transportation to a tertiary care center. If TXA is administered for a short duration (i.e., < 24 h), it may not increase the risk of DCI. The aim of this paper is to present in detail the statistical analysis plan (SAP) of the ULTRA trial (ULtra-early TRranexamic Acid after Subarachnoid Hemorrhage), which is currently enrolling patients and investigating whether ultraearly and short-term TXA treatment in patients with aneurysmal SAH improves clinical outcome at 6 months. METHODS/DESIGN: The ULTRA trial is a multicenter, prospective, randomized, open, blinded endpoint, parallel-group trial currently ongoing at 8 tertiary care centers and 16 of their referral centers in the Netherlands. Participants are randomized to standard care or to receive TXA at a loading dose of 1 g, immediately followed by 1 g every 8 h for a maximum of 24 h, in addition to standard care, as soon as SAH is diagnosed. In the TXA group, TXA administration is stopped immediately prior to treatment (coil or clip) of the causative aneurysm. Primary outcome is the modified Rankin Scale (mRS) score at 6 months after SAH, dichotomized into good (mRS 0-3) and poor (mRS 4-6) outcomes, assessed blind to treatment allocation. Secondary outcomes include case fatalities at 30 days and

Published
2020

17. Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage in Patients With a History of Migraine

Author

ZL Cerebrovasculaire Ziekten Medisch, Brain, Circulatory Health, Cardiovasculaire Epi Team 5, van Os, Hendrikus J A, Ruigrok, Ynte M, Verbaan, Dagmar, Dennesen, Paul, Müller, Marcella C A, Coert, Bert A, Algra, Ale, Vergouwen, Mervyn D I, Wermer, Marieke J H, ZL Cerebrovasculaire Ziekten Medisch, Brain, Circulatory Health, Cardiovasculaire Epi Team 5, van Os, Hendrikus J A, Ruigrok, Ynte M, Verbaan, Dagmar, Dennesen, Paul, Müller, Marcella C A, Coert, Bert A, Algra, Ale, Vergouwen, Mervyn D I, and Wermer, Marieke J H

Published
2020

18. Predicting Delayed Cerebral Ischemia with Quantified Aneurysmal Subarachnoid Blood Volume

Author

van der Steen, Wessel E., Marquering, Henk A., Boers, Anna M.M., Ramos, Lucas A., van den Berg, René, Vergouwen, Mervyn D.I., Majoie, Charles B.L.M., Coert, Bert A., Vandertop, William P., Verbaan, Dagmar, Roos, Yvo B.W.E.M., van der Steen, Wessel E., Marquering, Henk A., Boers, Anna M.M., Ramos, Lucas A., van den Berg, René, Vergouwen, Mervyn D.I., Majoie, Charles B.L.M., Coert, Bert A., Vandertop, William P., Verbaan, Dagmar, and Roos, Yvo B.W.E.M.

Published
2019

19. Predicting Delayed Cerebral Ischemia with Quantified Aneurysmal Subarachnoid Blood Volume

Author

van der Steen, Wessel E., Marquering, Henk A., Boers, Anna M.M., Ramos, Lucas A., van den Berg, René, Vergouwen, Mervyn D.I., Majoie, Charles B.L.M., Coert, Bert A., Vandertop, William P., Verbaan, Dagmar, Roos, Yvo B.W.E.M., van der Steen, Wessel E., Marquering, Henk A., Boers, Anna M.M., Ramos, Lucas A., van den Berg, René, Vergouwen, Mervyn D.I., Majoie, Charles B.L.M., Coert, Bert A., Vandertop, William P., Verbaan, Dagmar, and Roos, Yvo B.W.E.M.

Published
2019

20. Predicting Delayed Cerebral Ischemia with Quantified Aneurysmal Subarachnoid Blood Volume

Author

van der Steen, Wessel E., Marquering, Henk A., Boers, Anna M.M., Ramos, Lucas A., van den Berg, René, Vergouwen, Mervyn D.I., Majoie, Charles B.L.M., Coert, Bert A., Vandertop, William P., Verbaan, Dagmar, Roos, Yvo B.W.E.M., van der Steen, Wessel E., Marquering, Henk A., Boers, Anna M.M., Ramos, Lucas A., van den Berg, René, Vergouwen, Mervyn D.I., Majoie, Charles B.L.M., Coert, Bert A., Vandertop, William P., Verbaan, Dagmar, and Roos, Yvo B.W.E.M.

Published
2019

21. Predicting Delayed Cerebral Ischemia with Quantified Aneurysmal Subarachnoid Blood Volume

Author

UMC Utrecht, ZL Cerebrovasculaire Ziekten Medisch, Brain, Circulatory Health, van der Steen, Wessel E., Marquering, Henk A., Boers, Anna M.M., Ramos, Lucas A., van den Berg, René, Vergouwen, Mervyn D.I., Majoie, Charles B.L.M., Coert, Bert A., Vandertop, William P., Verbaan, Dagmar, Roos, Yvo B.W.E.M., UMC Utrecht, ZL Cerebrovasculaire Ziekten Medisch, Brain, Circulatory Health, van der Steen, Wessel E., Marquering, Henk A., Boers, Anna M.M., Ramos, Lucas A., van den Berg, René, Vergouwen, Mervyn D.I., Majoie, Charles B.L.M., Coert, Bert A., Vandertop, William P., Verbaan, Dagmar, and Roos, Yvo B.W.E.M.

Published
2019

22. Ultra-early tranexamic acid after subarachnoid hemorrhage (ULTRA): study protocol for a randomized controlled trial

Author

Germans, Menno R, Post, René, Coert, Bert A, Rinkel, Gabriël J E, Vandertop, W Peter, Verbaan, Dagmar, Germans, Menno R, Post, René, Coert, Bert A, Rinkel, Gabriël J E, Vandertop, W Peter, and Verbaan, Dagmar

Abstract

BACKGROUND A frequent complication in patients with subarachnoid hemorrhage (SAH) is recurrent bleeding from the aneurysm. The risk is highest within the first 6 hours after the initial hemorrhage. Securing the aneurysm within this timeframe is difficult owing to logistical delays. The rate of recurrent bleeding can also be reduced by ultra-early administration of antifibrinolytics, which probably improves functional outcome. The aim of this study is to investigate whether ultra-early and short-term administration of the antifibrinolytic agent tranexamic acid (TXA), as add-on to standard SAH management, leads to better functional outcome. METHODS/DESIGN This is a multicenter, prospective, randomized, open-label trial with blinded endpoint (PROBE) assessment. Adult patients with the diagnosis of non-traumatic SAH, as proven by computed tomography (CT) within 24 hours after the onset of headache, will be randomly assigned to the treatment group or the control group. Patients in the treatment group will receive standard treatment with the addition of a bolus of TXA (1 g intravenously) immediately after randomization, followed by continuous infusion of 1 g per 8 hours until the start of aneurysm treatment, or a maximum of 24 hours after the start of medication. Patients in the control group will receive standard treatment without TXA. The primary outcome measure is favorable functional outcome, defined as a score of 0 to 3 on the modified Rankin Scale (mRS), at 6 months after SAH. Primary outcome will be determined by a trial nurse blinded for treatment allocation. We aim to include 950 patients in 3 years. DISCUSSION The strengths of this study are: 1. the ultra-early and short-term administration of TXA, resulting in a lower dose as compared to previous studies, which should reduce the risk for delayed cerebral ischemia (DCI), an important risk factor in the long-term treatment with antifibrinolytics; 2. the power calculation is based on functional outcome and calcula

Published
2013

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