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

Last updated: January 5, 2025
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Not Recruiting

Phase

4

Condition

Circulation Disorders

Williams Syndrome

Brain Injury

Treatment

intravenous tranexamic acid (TXA) infusion

Placebo

Clinical Study ID

NCT06760078
TIME-ICH
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age between 18 to 80 years old;

  2. A definite diagnosis of supratentorial brain parenchymal hemorrhage by non-contrastcranial CT scan;

  3. Hemorrhage volume less than 40 mL, as calculated using the ABC/2 method, withultra-early hemorrhage growth (uHG) 10 mL/h or higher;

  4. A clear time of symptom onset, and the randomization must occur within 2 hours fromthe onset;

  5. At least two measurements of systolic blood pressure that are ≥150 mmHg and <220mmHg, 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

Exclusion Criteria:

  1. Pre-illness mRS > 2;

  2. Primary thalamic hemorrhage or intracerebral hemorrhage that has extended into theventricles;

  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

Total Participants: 532
Treatment Group(s): 2
Primary Treatment: intravenous tranexamic acid (TXA) infusion
Phase: 4
Study Start date:
December 31, 2024
Estimated Completion Date:
July 01, 2026

Study 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.

Connect with a study center

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing 100053
    China

    Site Not Available

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