Tranexamic Acid for Spontaneous Acute Cerebral Hemorrhage Trial
Status:
Unknown status
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
Summary
This study aims to explore the effectiveness of tranexamic acid (also known as trans amine or
TXA) in reducing hematoma expansion in patients with hemorrhagic stroke when given in the
acute phase.
METHODOLOGY
This will be a Phase III, parallel-group double-blind randomised placebo control trial.
Patients allocated to the control group will receive standard care for hemorrhagic stroke
according to the 2015 American Heart Association guidelines. Patients allocated to the
intervention group will receive, in addition to standard care, a loading dose of intravenous
TXA 1gm within 3 hours of symptom onset followed by a 1gm maintenance dose over 8 hours.
Timing and dosing are in accordance to previous established study protocols. Patients in the
intervention group will only receive a single treatment course of TXA.
Study subjects will be identified by either the on-duty clinicians from the Department of
Neurosurgery of this institution or by the study investigators. Should the patient meet study
eligibility criteria consent will be obtained either from the patient or from his/her next of
kin. 1:1 block randomization will be performed by a remote internet randomization service by
accessing a website. Patients allocated to the intervention arm will have 1gm of TXA added to
100ml of normal saline (0.9%) infused over 10 minutes as a loading dose. This is then
followed by a maintenance dose of 1gm of TXA in 500ml of intravenous isotonic solution
infused at 120mg/hour (60ml/hour) for 8 hours. Patient's allocated to the control arm will
have an equal volume of normal saline (0.9%) infused as a placebo. The patient and the
outcome assessor will be blinded to study group allocation.
The primary endpoint of this study will be to assess the percentage change in brain blood
clot volume by computed tomography brain scans on admission, 6 hours later, at 24 hours and
at 1 week.