Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage

Phase 4

Not yet recruiting

• Conditions: Spontaneous Intracranial Hemorrhage; Hypertension
• Interventions: Drug: intravenous tranexamic acid (TXA) infusion; Drug: Placebo

• Registration Number: NCT06760078
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

This is a prospective, multicenter, randomized, quadruple-blind, placebo-controlled study. This study aims to estimate the safety and efficacy of intravenous tranexamic acid (TXA) combined with intensive blood pressure lowering in ultra-early spontaneous intracerebral hemorrhage (ICH).

Detailed Description

This trial is designed to evaluate whether tranexamic acid can reduce hematoma expansion and improve functional outcomes when combined with intensive blood pressure lowering in cases of ultra-early intracerebral hemorrhage with a high risk of hematoma expansion.

Participants who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to either the TXA therapy group or the placebo control group. The initial infusion of 1 g of TXA or a matching placebo, along with intensive blood pressure lowering treatment, should commence as quickly as possible, ideally within 30 minutes of randomization. Following this, an additional 1 gram of TXA or a corresponding placebo will be administered via continuous intravenous infusion over 8 hours. Both groups will receive intensive blood pressure management during the first 24 hours after the onset of symptoms. Participants will be followed for 90 days after randomization for efficacy and safety outcomes.

Study Timeline

• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2024-12-30
• Study Start: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-05
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-12-31
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 532

Inclusion Criteria

1. Age between 18 to 80 years old;
2. A definite diagnosis of supratentorial brain parenchymal hemorrhage by non-contrast cranial CT scan;
3. Hemorrhage volume less than 40 mL, as calculated using the ABC/2 method, with ultra-early hemorrhage growth (uHG) 10 mL/h or higher;
4. A clear time of symptom onset, and the randomization must occur within 2 hours from the onset;
5. At least two measurements of systolic blood pressure that are ≥150 mmHg and <220 mmHg, with at least a 2-minute interval between measurements.;
6. Baseline NIHSS of 8 or higher, or unilateral limb muscle strength of 0-3 grades;
7. GCS score greater than 8;
8. The patient or their legal representative has signed an informed consent form.

Exclusion Criteria

1. Pre-illness mRS > 2;
2. Primary thalamic hemorrhage or intracerebral hemorrhage that has extended into the ventricles;
3. Scheduled for surgical intervention (i.e., hematoma evacuation, craniectomy);
4. Secondary ICH from tumors, AVMs, and aneurysms;
5. Traumatic brain injury-related hemorrhage;
6. Recent stroke, TIA, or thrombolytic therapy;
7. On anticoagulants;
8. Blood disorders, platelets <50,000/µL, or INR ≥1.8;
9. Antihypertensive therapy contraindications;
10. Indications for immediate blood pressure reduction;
11. Active thrombosis or thromboembolic history;
12. Hereditary or acquired thrombophilia;
13. Acquired color vision deficiency;
14. Epilepsy history;
15. GFR <90 mL/min;
16. Elevated ALT or liver disease;
17. Allergy to TXA or antifibrinolytics;
18. Life expectancy <12 months;
19. Pregnant or lactating women;
20. In other interventional clinical trials;
21. Other investigator-defined ineligibilities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid (TXA) group	intravenous tranexamic acid (TXA) infusion	Intravenous tranexamic acid 1 g over 10 minutes, followed by 1 g over 8 hours, with intensive blood pressure lowering.
Control group	Placebo	An intravenous placebo (normal saline) over 10 minutes, followed by another continuous infusion of placebo over 8 hours, with intensive blood pressure lowering maintained.

Primary Outcome Measures

Name	Time	Method
modified Rankin Scale (mRS) of 0-3 at 90 days	90 ± 7 days

Secondary Outcome Measures

Name	Time	Method
Hematoma expansion at 24 hours	24±3 hours	The expansion is defined as a 33% or 6 mL increase from baseline hematoma volume or develop an intraventricular hemorrhage.
Absolute intracerebral haematoma growth at 24 hours	24±3 hours
Relative intracerebral haematoma growth at 24 hours	24±3 hours
Intraventricular hematoma (IVH) growth at 24 hours	24±3 hours
National Institutes of Health Stroke Scale (NIHSS) score at 24 hours	24±3 hours
Neurologic deterioration in first 24 hours	24±3 hours	Neurologic deterioration is defined as an increase of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) from baseline to 24 hours, or a decline of 2 or more points on the Glasgow Coma Scale (GCS).
modified Rankin Scale (mRS) score at 90 days	90±7 days
Received surgical intervention within 7 days	Within 7±3 days	Interventions include hematoma evacuation, external ventricular drainage, and craniectomy.
modified Rankin Scale (mRS) score of 0-4 at 90 days	90±7 days
Utility weighted modified Rankin Scale (mRS) score at 90 days	90±7 days
Major thromboembolic events	Within 90±7 days	This includes ischemic stroke, myocardial infarction, and pulmonary embolism.
Death due to any cause within 90 days	Within 90±7 days
Severe hypotension	Within 72 hours	Hypotension with clinical consequences (including acute renal failure) that required corrective therapy with intravenous fluids, vasopressors, or hemodialysis.

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China