Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage.
Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Feb 12, 2016
Trial Information
Current as of April 26, 2025
Completed
Keywords
ClinConnect Summary
Approximately 50% of all patients with a subarachnoid hemorrhage (SAH) die due to the hemorrhage or subsequent complications. There are several major causes for this course, such as in-hospital rebleed in 21.5% which most frequently occurs within the first 6 hours after the primary hemorrhage ("ultra-early rebleed"). A major part of the patients with a rebleed die during hospital admission and when they survive, they develop more severe cognitive dysfunctions. Reducing the rebleeds by ultra-early administration of tranexamic acid (TXA) could be a major factor in improving the functional out...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Admission to one of the study centers or their referring hospitals
- • CT-confirmed SAH with most recent ictus less than 24 hours ago Definition: subarachnoid hemorrhage is a bleeding pattern on computed tomography with hyperdensity in the basal cisterns and/or Sylvian or interhemipheric fissures or a intraparenchymal hyperdensity consistent with a hematoma from an anterior, a pericallosal, a posterior or a middle cerebral artery aneurysm.
- Exclusion Criteria:
- • No proficiency of the Dutch or English language
- • No loss of consciousness after the hemorrhage with WFNS grade 1 or 2 on admission in combination with a perimesencephalic hemorrhage Definition: on CT examination presence of hyperdensities exclusively in the basal cisterns maximal extending to the proximal part of the Sylvian fissure or posterior part of the interhemispheric fissure, without evidence for intracerebral or intraventricular haemorrhage (except slight sedimentation)
- • Bleeding pattern on CT compatible with a traumatic SAH
- • Treatment for deep vein thrombosis or pulmonary embolism
- • History of a blood coagulation disorder (a hypercoagulability disorder)
- • Pregnancy checked with a pregnancy test in women in their childbearing period
- • History of severe renal (serum creatinin \>150 mmol/L)
- • History of severe liver failure (AST \> 150 U/l or ALT \> 150 U/l or AF \> 150 U/l or γ-GT \> 150 U/l)
- • Imminent death within 24 hours
About Academisch Medisch Centrum Universiteit Van Amsterdam (Amc Uva)
The Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is a leading academic medical center in the Netherlands, dedicated to advancing healthcare through innovative research, education, and patient care. Affiliated with the University of Amsterdam, AMC-UvA integrates clinical practice with cutting-edge biomedical research, fostering a multidisciplinary approach to medical challenges. The institution actively engages in clinical trials to enhance treatment options and improve patient outcomes, while promoting collaboration among healthcare professionals, researchers, and academic institutions globally. With a commitment to excellence and a focus on translational medicine, AMC-UvA plays a pivotal role in shaping the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Amsterdam, , Netherlands
Patients applied
Trial Officials
William P Vandertop, PhD MD
Principal Investigator
Department of Neurosurgery
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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