Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage (TIME-ICH)

Capital Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Hypertension; Spontaneous Intracranial Hemorrhage

Treatments: Drug: intravenous tranexamic acid (TXA) infusion; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06760078

TIME-ICH

Details and patient eligibility

About

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).

Full 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.

Enrollment: 532 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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532 participants in 2 patient groups, including a placebo group

Tranexamic acid (TXA) group

Experimental group

Description:

Intravenous tranexamic acid 1 g over 10 minutes, followed by 1 g over 8 hours, with intensive blood pressure lowering.

Treatment:

Drug: intravenous tranexamic acid (TXA) infusion

Control group

Placebo Comparator group

Description:

An intravenous placebo (normal saline) over 10 minutes, followed by another continuous infusion of placebo over 8 hours, with intensive blood pressure lowering maintained.

Treatment:

Drug: Placebo