NCT07365150 Precision Use of TXA in Intracerebral Hemorrhage
| NCT ID | NCT07365150 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Intracerebral Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2026-01-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Primary Intracerebral hemorrhage (ICH) is a severe and disabling disease. The hematoma will expand within the first few hours, which contributes to increasing brain injury and worsening neurological prognosis. Hence, one of ICH's main acute therapeutic strategies is to reduce hematoma expansion (HE) with hemostatic agents like tranexamic acid (TXA) or recombinant factor VIIa. However, although most HE trials have demonstrated that treatment attenuated HE, they have largely been unable to demonstrate therapeutic benefit in improving functional outcomes. The lack of outcome benefits for ICH treatment is because therapeutic benefits are significantly confounded by the outcome heterogeneity based on ICH location and the variation in the degree of HE between patients, which is not accounted for in all ICH trials. The investigators' recent work has examined the interplay between ICH location and volume in determining ICH pathophysiology and outcomes, highlighting a critical interaction between these factors and neurological prognosis. Also, as HE only occurs in 15-40% of patients, the therapeutic benefits of treatment targeting HE are not modifiable in most patients. Furthermore, only a minority of patients with HE experienced neurological deterioration (HE-related neurological deterioration) that could impact their neurological outcomes. There is also a location-specific variation in the risk of HE-related neurological deterioration, occurring at a larger baseline volume for ICH at putamen/ lobar compared to thalamus/ internal capsule. Hence, as outcome heterogeneity based on ICH location and the variation in the degree of HE significantly confounds therapeutic effect, better patient selection for hemostatic agents in ICH treatment is essential to yield functional benefit. To address this, a novel selection criteria (\>7ml for thalamus/ internal capsule, \>30ml for putamen/ lobar) is proposed, which, in theory, would account for the confounding effect of location-specific outcome heterogeneity and the location-based variation in HE-related neurological deterioration. Therefore, the PRECISE-TRANSACT trial aims to investigate whether TXA administration based on this selection criteria significantly reduces the risk of neurological deterioration and consequent therapeutic benefit.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07365150 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracerebral Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07365150 currently recruiting?
Yes, NCT07365150 is actively recruiting participants. Contact the research team at kcteo@hku.hk for enrollment information.
Where is the NCT07365150 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong, Hong Kong, Hong Kong, Hong Kong, Hong Kong.
Who is sponsoring the NCT07365150 clinical trial?
NCT07365150 is sponsored by The University of Hong Kong. The trial plans to enroll 70 participants.