Ultra-early tranexamic acid after subarachnoid hemorrhage.

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.



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.

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).

Primary 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.

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.



Control group:

Standard treatment with no TXA administration.