|- candidate number||11024|
|- NTR Number||NTR3272|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-jan-2012|
|- Secondary IDs||NL20120125 CCMO|
|- Public Title||Ultra-early tranexamic acid after subarachnoid hemorrhage.
|- Scientific Title||Ultra-early tranexamic acid after subarachnoid hemorrhage. A prospective, randomized, multicenter study.|
|- hypothesis||Patients 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) studied||Subarachnoid hemorrhage (SAH), Cerebral bleeding|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2013|
|- planned closingdate||1-apr-2019|
|- Target number of participants||950|
|- 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 maximum of 24 hours.
Standard treatment with no TXA administration.
|- Primary outcome||Modified Rankin Scale score dichotomized as a favourable (0-3) or unfavourable (4-6) outcome.|
|- Secondary outcome||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.
|- Timepoints||Primary outcome: Six months after SAH.
1. Six months after SAH;
2. Before or during aneurysm treatment;
3. During endovascular treatment;
4. During admission.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||PhD. D. Verbaan|
|- CONTACT for SCIENTIFIC QUERIES||PhD. D. Verbaan|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Approximately 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.
Multicenter, prospective, randomized trial with blind endpoint assessment.
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.
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)|
|- RECORD||25-jan-2012 - 24-dec-2015|