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Ultra-early tranexamic acid after subarachnoid hemorrhage.


- candidate number11024
- NTR NumberNTR3272
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jan-2012
- Secondary IDsNL20120125 CCMO
- Public TitleUltra-early tranexamic acid after subarachnoid hemorrhage.
- Scientific TitleUltra-early tranexamic acid after subarachnoid hemorrhage. A prospective, randomized, multicenter study.
- ACRONYMULTRA
- hypothesisPatients with subarachnoid hemorrhage (SAH) treated by standard, state-of-the-art SAH management with additional ultra-early and short-term TXA administration (TXA group) have significantly more often a favourable outcome after six months (score 0-3 on the Modified Rankin Scale) compared to a patients treated by standard, state-of-the-art SAH management without additional TXA administration (control group).
- Healt Condition(s) or Problem(s) studiedSubarachnoid hemorrhage (SAH), Cerebral bleeding
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2013
- planned closingdate1-apr-2019
- Target number of participants950
- InterventionsTXA 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 maximum of 24 hours.

Control group:
Standard treatment with no TXA administration.
- Primary outcomeModified Rankin Scale score dichotomized as a favourable (0-3) or unfavourable (4-6) outcome.
- Secondary outcome1. 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.
- TimepointsPrimary outcome: Six months after SAH.

Secondary outcomes:
1. Six months after SAH;
2. Before or during aneurysm treatment;
3. During endovascular treatment;
4. During admission.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD. D. Verbaan
- CONTACT for SCIENTIFIC QUERIESPhD. D. Verbaan
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryApproximately 50% of all patients with an subarachnoid hemorrhage (SAH) dies due to the hemorrhage or subsequent complications. There are several major causes for this course, such as in-hospital rebleed in 4-12% which most frequently occurs within the first 6 hours after the primary hemorrhage (“ultra-early rebleed”). Half 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 outcome after SAH.

Study design:
Multicenter, prospective, randomized trial with blind endpoint assessment.

Study population:
Adult patients (18 years and older) included within 24 hours after SAH.

Primary and secondary outcomes:
Primary: Dichotomized outcome at the Modified Rankin Scale after six months (0-3: favourable; 4-6: unfavourable).
Secondary: Case fatality rate, rebleed rate, thromboembolic complications, delayed cerebral ischemia rate, complications (hydrocephalus, thromboembolic events, extracranial thrombosis or hemorrhagic complications), care costs.

Intervention:
Group one: 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 maximum of 24 hours.
Group two: Standard treatment with no TXA administration.

Main study parameters/endpoints:
Primary: Modified Rankin Scale score after six months, dichotomized into favourable and unfavourable outcome.
Secondary: Rebleed and case fatality rate, complications during the first six months after hemorrhage and infarctions on MR-imaging at six months.
- Main changes (audit trail)
- RECORD25-jan-2012 - 24-dec-2015


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