Precision Use of TXA in Intracerebral Hemorrhage

NCT07365150 | Recruiting

• 1 other identifier: TKC202403
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

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.

Conditions

Intracerebral Hemorrhage

Keywords

Tranexamic acid; Intracerebral hemorrhage

Outcome Measures

Primary Outcomes (2)

• Trial recruitment rate

  Number of patients recruited per month

  At recruitment

• Trial retention rate

  Number of patients who completed follow-up

  Six months

Secondary Outcomes (4)

• The number of patients with early neurological deterioration

  24 hours of admission

• The number of patients with delayed neurological deterioration or any deterioration

  Day 2-7

• Modified Rankin Scale

  Six months

• Hematoma expansion

  24 hours

Other Outcomes (2)

• Thrombotic event

  30 days

• Mortality

  30 days

Study Arms (2)

TXA arm

ACTIVE COMPARATOR

TXA 1000mg stat over 10 minutes and 1000 mg over 8 hours

Drug: Tranexamic Acid (IV)

Control arm

NO INTERVENTION

No TXA

Interventions

Tranexamic Acid (IV) DRUG

TXA 1000mg stat over 10 minutes and 1000 mg over 8 hours

TXA arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Prince of Wales Hospital, Kong Kong: collaborator
• Pamela Youde Nethersole Eastern Hospital: collaborator

Study Sites (3)

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

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Kay Cheong Teo, MBBS, MD

CONTACT

852-22552368; kcteo@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor of clinical outcomes (GCS, NIHSS and mRS) and hematoma volume will be blinded to treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Pilot randomized controlled trial with PROBE design

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 26, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

HK (3)