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| Name | Class |
|---|---|
| Prince of Wales Hospital, Kong Kong | UNKNOWN |
| Pamela Youde Nethersole Eastern Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TXA arm | Active Comparator | TXA 1000mg stat over 10 minutes and 1000 mg over 8 hours |
|
| Control arm | No Intervention | No TXA |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid (IV) | Drug | TXA 1000mg stat over 10 minutes and 1000 mg over 8 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trial recruitment rate | Number of patients recruited per month | At recruitment |
| Trial retention rate | Number of patients who completed follow-up | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours of admission |
| The number of patients with delayed neurological deterioration or any deterioration |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombotic event | Any arterial or venous thrombotic events. | 30 days |
| Mortality | All caused death | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kay Cheong Teo, MBBS, MD | Contact | 852-22552368 | kcteo@hku.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pamela Youde Nethersole Eastern Hospital | Not yet recruiting | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Pilot randomized controlled trial with PROBE design
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Assessor of clinical outcomes (GCS, NIHSS and mRS) and hematoma volume will be blinded to treatment allocation
|
| 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. | Six months |
| Hematoma expansion | Increase in hematoma volume from baseline to reassessment imaging | 24 hours |
| Prince of Wales Hospital | Recruiting | Hong Kong | Hong Kong |
|
| The University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
|
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |