Precision Use of TXA in Intracerebral Hemorrhage

January 15, 2026 updated by: Teo Kay-Cheong, The University of Hong Kong

PRECISion usE of TRANexamic Acid for Supratentorial Acute Cerebral Hemorrhage Trial: a Pilot Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kay Cheong Teo, MBBS, MD
  • Phone Number: 852-22552368
  • Email: kcteo@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The University of Hong Kong
        • Contact:
          • Kay Cheong Teo
          • Phone Number: 852-22552368
          • Email: kcteo@hku.hk
      • Hong Kong, Hong Kong
      • Hong Kong, Hong Kong
        • Not yet recruiting
        • Pamela Youde Nethersole Eastern Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TXA arm
TXA 1000mg stat over 10 minutes and 1000 mg over 8 hours
Drug: Tranexamic Acid (IV)
TXA 1000mg stat over 10 minutes and 1000 mg over 8 hours
No Intervention: Control arm
No TXA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trial recruitment rate
Time Frame: At recruitment
Number of patients recruited per month
At recruitment
Trial retention rate
Time Frame: Six months
Number of patients who completed follow-up
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients with early neurological deterioration
Time Frame: 24 hours of admission
Early neurological deterioration is defined as ≥4-point increase in the National Institute of Health Stroke Scale (NIHSS) or ≥2-point decrease in the Glasgow Coma Scale (GCS) within 24 hours
24 hours of admission
The number of patients with delayed neurological deterioration or any deterioration
Time Frame: Day 2-7
  1. Delayed neurological deterioration is defined as ≥4-point increase in the NIHSS or ≥2-point decrease in the GCS within day 2-7.
  2. Any deterioration is defined as any deterioration in NIHSS, GCS, or limb power grade within 7 days.
Day 2-7
Modified Rankin Scale
Time Frame: Six months
Neurological recovery will be assessed using the Modified Rankin Scale (mRS), which ranges from 0 to 6, where 0 indicates no symptoms, 1-5 indicate increasing levels of neurological disability, and 6 indicates death.
Six months
Hematoma expansion
Time Frame: 24 hours
Increase in hematoma volume from baseline to reassessment imaging
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombotic event
Time Frame: 30 days
Any arterial or venous thrombotic events.
30 days
Mortality
Time Frame: 30 days
All caused death
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Pamela Youde Nethersole Eastern Hospital
Prince of Wales Hospital, Kong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TKC202403

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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