Precision Use of TXA in Intracerebral Hemorrhage

The University of Hong Kong (HKU)

Status

Enrolling

Conditions

Intracerebral Hemorrhage

Treatments

Drug: Tranexamic Acid (IV)

Study type

Interventional

Funder types

Other

Identifiers

NCT07365150

TKC202403

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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