Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage.
Status:
Completed
Trial end date:
2020-11-01
Target enrollment:
Participant gender:
Summary
This is a multicenter, prospective, randomized, open-label trial with blinded endpoint
(PROBE) assessment. Adult patients with the diagnosis of non-traumatic SAH, as proven by
computed tomography (CT) within 24 hours after the onset of headache, will be randomly
assigned to the treatment group or the control group. Patients in the treatment group will
receive standard treatment with the addition of a bolus of TXA (1 g intravenously)
immediately after randomization, followed by continuous infusion of 1 g per 8 hours until the
start of aneurysm treatment, or a maximum of 24 hours after the start of medication. Patients
in the control group will receive standard treatment without TXA. The primary outcome measure
is favorable functional outcome, defined as a score of 0 to 3 on the modified Rankin Scale
(mRS), at 6 months after SAH. Primary outcome will be determined by a trial nurse blinded for
treatment allocation.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)