Precision Use of TXA in Intracerebral Hemorrhage

Recruiting now · Not applicable

Conditions studied: Intracerebral Hemorrhage

In brief

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.

Key facts

Study ID

NCT07365150

Run by

The University of Hong Kong

People needed

70

Starts

2026-01-01

Expected to finish

2027-12-31

Last updated by the study team

2026-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 it is running

• Prince of Wales Hospital — Hong Kong, Hong Kong (enrolling)
• The University of Hong Kong — Hong Kong, Hong Kong (enrolling)
• Pamela Youde Nethersole Eastern Hospital — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

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