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17 results on '"Koopman, Inez"'

3. Safety and pharmacodynamic efficacy of eculizumab in aneurysmal subarachnoid hemorrhage (CLASH): A phase 2a randomized clinical trial

Author

Koopman, Inez, primary, Tack, Reinier WP, additional, Wunderink, Herman F, additional, Bruns, Anke HW, additional, van der Schaaf, Irene C, additional, Cianci, Daniela, additional, Gelderman, Kyra A, additional, van de Ridder, Inge M, additional, Hol, Elly M, additional, Rinkel, Gabriel JE, additional, and Vergouwen, Mervyn DI, additional

Published
2023
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6. Rebleeding After Aneurysmal Subarachnoid Hemorrhage in Two Centers Using Different Blood Pressure Management Strategies

Author

Calviere, Lionel, primary, Gathier, Celine S., additional, Rafiq, Marie, additional, Koopman, Inez, additional, Rousseau, Vanessa, additional, Raposo, Nicolas, additional, Albucher, Jean François, additional, Viguier, Alain, additional, Geeraerts, Thomas, additional, Cognard, Christophe, additional, Rinkel, Gabriel J. E., additional, Vergouwen, Mervyn D. I., additional, and Olivot, Jean-Marc, additional

Published
2022
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7. Deferred Consent in an Acute Stroke Trial from a Patient, Proxy, and Physician Perspective: A Cross-Sectional Survey

Author

Koopman, Inez, primary, Verbaan, Dagmar, additional, Vandertop, W. Peter, additional, van der Graaf, Rieke, additional, Kompanje, Erwin J. O., additional, Post, René, additional, Coert, Bert A., additional, Ploem, Martine C., additional, Sluis, Wouter M., additional, Scheijmans, Féline E. V., additional, Rinkel, Gabriel J. E., additional, and Vergouwen, Mervyn D. I., additional

Published
2021
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13. Supplemental material for Aneurysm characteristics and risk of rebleeding after subarachnoid haemorrhage

Author

Koopman, Inez, Greving, Jacoba P, Schaaf, Irene C Van Der, Zwan, Albert Van Der, Rinkel, Gabriel JE, and Vergouwen, Mervyn DI

Subjects
FOS: Clinical medicine, Cardiology, Medicine, 110904 Neurology and Neuromuscular Diseases
Abstract

Supplemental material for Aneurysm characteristics and risk of rebleeding after subarachnoid haemorrhage by Inez Koopman, Jacoba P Greving, Irene C van der Schaaf, Albert van der Zwan, Gabriel JE Rinkel and Mervyn DI Vergouwen in European Stroke Journal

Published
2018
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16. Abstract 96: CompLement C5 Antibodies For Decreasing Brain Injury After Aneurysmal Subarachnoid Hemorrhage (CLASH): A Randomized Controlled Phase II Clinical Trial

Author

Koopman, Inez, Tack, Reinier W, Rinkel, Gabriel J, and Vergouwen, Mervyn D

Abstract

Introduction:The inflammatory response after aneurysmal subarachnoid hemorrhage (aSAH) has been associated with early brain injury, delayed cerebral ischemia, and poor functional outcome. In experimental SAH studies, complement C5 antibodies administered shortly after SAH reduced brain injury with approximately 40%. We investigated the pharmacodynamic efficacy and safety of eculizumab (a complement C5 antibody) in aSAH patients.Methods:We conducted a randomized, controlled, open-label, phase II clinical trial with blinded outcome assessment in the Netherlands. Patients were randomized (1:1) to receive eculizumab plus standard care or to standard care alone. Eculizumab (1200 mg) was administered intravenously < 12 h, on day 3 and on day 7 after ictus. Patients in the intervention group received prophylactic antibiotics for 4 weeks and prophylactic antifungal therapy if the patient had a central line or an external ventricular shunt and a positive fungal or yeast culture. The primary outcome was C5a concentration in the cerebrospinal fluid (CSF) on day 3 after ictus. Secondary outcomes included the occurrence of adverse events, eculizumab concentration and inflammatory parameters in the blood and CSF, cerebral infarction on magnetic resonance imaging, and clinical and cognitive outcomes. We aimed to evaluate 26 patients with CSF assessments, 13 in the intervention group and 13 in the comparator group.Results:A total of 31 patients have been included, of which 26 with CSF samples.Conclusions:Final results will be presented at the conference.Trial registration:Netherlands Trial Register: NTR6752. European Clinical Trials Database (EudraCT): 2017-004307-51.

Published
2022
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17. CompLement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Haemorrhage (CLASH): study protocol for a randomised controlled phase II clinical trial.

Author

Koopman, Inez, Rinkel, Gabriel J. E., Vergouwen, Mervyn D. I., on behalf of the CLASH study group, Koopman, I., Tack, R. W. P., Wunderink, H. F., Bruns, A. H. W., van der Schaaf, I., Gelderman, K. A., Greving, J. P., Slooter, A. J. C., van der Zwan, A., Bartels, M., Rinkel, G. J. E., Vergouwen, M. D. I., and CLASH study group

Subjects
*SUBARACHNOID hemorrhage, *BRAIN injuries, *CLINICAL trials, *CEREBROSPINAL fluid shunts, *INFLAMMATION, *IMMUNOGLOBULINS, *CEREBROSPINAL fluid
Abstract

Background: The inflammatory response after aneurysmal subarachnoid haemorrhage (aSAH) has been associated with early brain injury, delayed cerebral ischaemia, poor functional outcome, and case fatality. In experimental SAH studies, complement C5 antibodies administered shortly after SAH reduced brain injury with approximately 40%. Complement component C5 may be a new therapeutic target to reduce brain injury and hereby improve the outcome after aSAH. We aim to investigate the pharmacodynamic efficacy and safety of eculizumab (complement C5 antibody) in patients with aSAH.Methods: A randomised, controlled, open-label, phase II clinical trial with blinded outcome assessment. Eculizumab (1200 mg) is administered intravenously < 12 h, on day 3 and on day 7 after ictus. Patients in the intervention group receive prophylactic antibiotics for 4 weeks, and those with a central line or an external ventricular shunt and a positive fungal or yeast culture also receive prophylactic antifungal therapy for 4 weeks. The primary outcome is C5a concentration in the cerebrospinal fluid (CSF) on day 3 after ictus. Secondary outcomes include the occurrence of adverse events, inflammatory parameters in the blood and CSF, cerebral infarction on magnetic resonance imaging, and clinical and cognitive outcomes. We aim to evaluate 26 patients with CSF assessments, 13 in the intervention group and 13 in the comparator group. To compensate for early case fatality and inability to obtain CSF, we will include 20 patients per group.Discussion: The CLASH trial is the first trial to investigate the pharmacodynamic efficacy and safety of eculizumab in the early phase after aSAH.Trial Registration: Netherlands Trial Register NTR6752 . Registered on 27 October 2017 European Clinical Trials Database (EudraCT) 2017-004307-51. [ABSTRACT FROM AUTHOR]

Published
2020
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