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Ultra-early tranexamic acid after subarachnoid hemorrhage.

Ultra-early tranexamic acid after subarachnoid hemorrhage. A prospective, randomized, multicenter study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22386
Enrollment
950
Registered
2012-01-25
Start date
2013-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

subarachnoid hemorrhage intracerebral hemorrhage subarachnoidale bloeding hersenbloeding

Interventions

TXA group: Standard treatment with additional administration of 1 g TXA intravenously in ten minutes, immediately after the diagnosis SAH, succeeded by continuous infusion of 1 g per 8 hours until a

Sponsors

Academic Medical Center Meibergdreef 9 1105 AZ Amsterdam Tel: 020-5666564 Fax: 020-5669590
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Admission to one of the study centers or their referring hospitals; 2. CT-confirmed SAH with ictus less than 24 hours ago; 3. Age 18 years and older; 4. Informed consent.

Exclusion criteria

Exclusion criteria: 1. No loss of consciousness after the hemorrhage with WFNS grade 1 or 2 on admission in combination with a perimesencephalic hemorrhage; 2. Bleeding pattern on CT compatible with a traumatic SAH; 3. Treatment for deep vein thrombosis; 4. History of blood coagulation disorder; 5. Pregnancy or breastfeeding; 6. Severe renal (serum creatinin >150 mmol/L) or liver failure (AST > 150 U/l or ALT > 150 U/l or AF > 150 U/l or ã-GT > 150 U/l); 7. Imminent death within 24 hours.

Design outcomes

Primary

MeasureTime frame
Modified Rankin Scale score dichotomized as a favourable (0-3) or unfavourable (4-6) outcome.

Secondary

MeasureTime frame
1. Case fatality rate; 2. Cause of poor outcome; 3. Rebleed rate; 4. Thromboembolic complications; 5. Delayed cerebral ischemia rate; 6. Complications (hydrocephalus, thromboembolic events, extracranial thrombosis or hemorrhagic complications); 7. Care costs.

Contacts

Public ContactD. Verbaan

AMC Meibergdreef 9

D.Verbaan@amc.uva.nl+31 (0)20 5666564

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)