Intracerebral HemorrhageNCT07365150
Precision Use of TXA in Intracerebral Hemorrhage
A study testing Tranexamic Acid (IV) in people with Intracerebral Hemorrhage, run by The University of Hong Kong at 3 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Tranexamic Acid (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesHong Kong
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- Inability to participate in follow-up activity
- Bleeding tendency
- Severe renal impairment
- Severe liver impairment
- Known contraindication or allergy to tranexamic acid
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong3 sites, 3 recruiting
- Not yet recruiting
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Richard Li, 852-25956412, lir@ha.org.hk
- Recruiting
Prince of Wales Hospital
Hong Kong
Peter Woo, 852-35051316, peterwoo@surgery.cuhk.edu.hk
- Recruiting
The University of Hong Kong
Hong Kong
Kay Cheong Teo, 852-22552368, kcteo@hku.hk
About this study
Official title: 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.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Tranexamic Acid (IV)
- Keywords
- Tranexamic acid, Intracerebral hemorrhage
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (IV)Drug
TXA 1000mg stat over 10 minutes and 1000 mg over 8 hours
| Study group | Role | What they receive |
|---|---|---|
| TXA arm | Active comparator | TXA 1000mg stat over 10 minutes and 1000 mg over 8 hours Receives: Drug: Tranexamic Acid (IV) |
| Control arm | No intervention | No TXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial recruitment rate
Number of patients recruited per month
Measured: At recruitment
Trial retention rate
Number of patients who completed follow-up
Measured: Six months
Secondary outcomes (4)
The number of patients with early neurological deterioration
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
Measured: 24 hours of admission
The number of patients with delayed neurological deterioration or any deterioration
- Delayed neurological deterioration is defined as ≥4-point increase in the NIHSS or ≥2-point decrease in the GCS within day 2-7.
- Any deterioration is defined as any deterioration in NIHSS, GCS, or limb power grade within 7 days.
Measured: Day 2-7
Modified Rankin Scale
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.
Measured: Six months
Hematoma expansion
Increase in hematoma volume from baseline to reassessment imaging
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized controlled trial with PROBE design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Pamela Youde Nethersole Eastern Hospital
- Responsible party
- Principal investigator, Teo Kay-Cheong, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365150
- Sponsor's protocol ID
- TKC202403
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRECISion usE of TRANexamic Acid for Supratentorial Acute Cerebral Hemorrhage Trial: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07365150
- Acronym / sponsor ID
- TKC202403
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Tranexamic acid, Intracerebral hemorrhage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Pamela Youde Nethersole Eastern Hospital
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot randomized controlled trial with PROBE design
| Arm | Type | Receives |
|---|---|---|
| TXA arm | Active comparator | Drug: Tranexamic Acid (IV)TXA 1000mg stat over 10 minutes and 1000 mg over 8 hours |
| Control arm | No intervention | –No TXA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary ICH Diagnosis
- Age ≥ 18 years
- Within 6 hours of ICH
- Supratentorial ICH
- GCS ≥8
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid (IV)TXA 1000mg stat over 10 minutes and 1000 mg over 8 hours | Drug | TXA arm |
Primary outcome
Trial recruitment rate
Time frame: At recruitment
Number of patients recruited per month
Trial retention rate
Time frame: Six months
Number of patients who completed follow-up
4 secondary outcomes
The number of patients with early neurological deterioration
Time frame: 24 hours of admission
The number of patients with delayed neurological deterioration or any deterioration
Time frame: Day 2-7
Modified Rankin Scale
Time frame: Six months
Hematoma expansion
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid (IV) in people with Intracerebral Hemorrhage, run by The University of Hong Kong at 3 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kay Cheong Teo, MBBS, MD (852-22552368, kcteo@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trial recruitment rate (time frame: At recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.