Intracerebral Hemorrhage
Conditions
Keywords
Tranexamic acid, Intracerebral hemorrhage
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.
Interventions
TXA 1000mg stat over 10 minutes and 1000 mg over 8 hours
Sponsors
The University of Hong Kong
Prince of Wales Hospital, Kong Kong
Pamela Youde Nethersole Eastern Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessor of clinical outcomes (GCS, NIHSS and mRS) and hematoma volume will be blinded to treatment allocation
Intervention model description
Pilot randomized controlled trial with PROBE design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trial recruitment rate | At recruitment | Number of patients recruited per month |
| Trial retention rate | Six months | Number of patients who completed follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of patients with early neurological deterioration | 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 |
| The number of patients with delayed neurological deterioration or any deterioration | 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. |
| Modified Rankin Scale | 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. |
| Hematoma expansion | 24 hours | Increase in hematoma volume from baseline to reassessment imaging |
Countries
Hong Kong
Contacts
CONTACTKay Cheong Teo, MBBS, MD
Outcome results
None listed