Precision use of tranexamic acid for intracerebral hemorrhage
PRECISion usE of TRANexamic Acid for Supratentorial Acute Cerebral Hemorrhage Trial: a Pilot Randomized Controlled Trial
This study will try giving intravenous tranexamic acid to adults with certain supratentorial intracerebral hemorrhages within 6 hours to see if it limits hematoma growth and improves recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 3 sites (Hong Kong and 2 other locations) |
| Trial ID | NCT07365150 on ClinicalTrials.gov |
What this trial studies
This interventional protocol enrolls adults with primary supratentorial intracerebral hemorrhage who present within 6 hours and meet location-specific hematoma volume thresholds. Eligible participants receive intravenous tranexamic acid with the aim of reducing early hematoma expansion in patients at highest risk. The design intentionally enriches enrollment by ICH location and size to reduce outcome heterogeneity that has limited prior hemostatic trials. Key outcomes include hematoma growth and functional recovery measured during follow-up.
Who should consider this trial
Good fit: Adults (≥18) with primary supratentorial ICH presenting within 6 hours, GCS ≥8, meeting location-specific volume criteria and without contraindications to tranexamic acid are the intended candidates.
Not a fit: Patients with infratentorial hemorrhages, late presentation beyond 6 hours, significant pre-existing disability, anticoagulation use, planned surgery, or contraindications to tranexamic acid are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, targeted use of tranexamic acid could reduce hematoma expansion and translate into better neurological outcomes for selected ICH patients.
How similar studies have performed: Previous trials of tranexamic acid and other hemostatic agents often reduced hematoma expansion but generally failed to show clear improvements in functional outcomes, making this targeted approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary ICH Diagnosis * Age ≥ 18 years * Within 6 hours of ICH * Supratentorial ICH * GCS ≥8 * Location-specific volume criteria (\>7ml for thalamus or internal capsule; \>30ml for putamen or lobar) Exclusion Criteria: * Severe pre-morbid disability (Pre-morbid modified Rankin scale 5) * Anticipated surgical treatment * Recent acute atherosclerotic cardiovascular diseases (e.g. acute coronary syndrome, ischemic stroke) * Receiving anticoagulation * Recent intravascular stent placement and on dual antiplatelet treatment * Expected life expectancy of \<1 year * Inability to participate in follow-up activity * Bleeding tendency * Severe renal impairment * Severe liver impairment * Known contraindication or allergy to tranexamic acid
Where this trial is running
Hong Kong and 2 other locations
- Pamela Youde Nethersole Eastern Hospital — Hong Kong, Hong Kong (Not_yet_recruiting)
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
- The University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Kay Cheong Teo, MBBS, MD
- Email: kcteo@hku.hk
- Phone: 852-22552368
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.