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

NCT ID: NCT06760078

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 532 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2026-07-01

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.

Conditions

Spontaneous Intracranial Hemorrhage; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tranexamic acid (TXA) group

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

Group Type: EXPERIMENTAL

intravenous tranexamic acid (TXA) infusion

Intervention Type: DRUG

Intravenous tranexamic acid will be administered as an initial dose of 1 g (10mL: 1g, diluted in 90 mL normal saline) over 10 minutes, followed by a maintenance dose of 1 g over 8 hours (10mL: 1g, diluted in 240 mL normal saline). Intensive blood pressure lowering will be maintained throughout the treatment period until 24 hours after onset.

Control group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

An intravenous placebo (10mL NS, diluted in 90mL NS) matching the specification and appearance of TXA will be administered as an initial bolus over 10 minutes, followed by a continuous infusion of placebo (10mL NS, diluted in 240mL NS) over 8 hours, with intensive blood pressure lowering maintained throughout the treatment period and continued until 24 hours after symptoms onset.

Interventions

intravenous tranexamic acid (TXA) infusion

Intravenous tranexamic acid will be administered as an initial dose of 1 g (10mL: 1g, diluted in 90 mL normal saline) over 10 minutes, followed by a maintenance dose of 1 g over 8 hours (10mL: 1g, diluted in 240 mL normal saline). Intensive blood pressure lowering will be maintained throughout the treatment period until 24 hours after onset.

Intervention Type: DRUG

Placebo

An intravenous placebo (10mL NS, diluted in 90mL NS) matching the specification and appearance of TXA will be administered as an initial bolus over 10 minutes, followed by a continuous infusion of placebo (10mL NS, diluted in 240mL NS) over 8 hours, with intensive blood pressure lowering maintained throughout the treatment period and continued until 24 hours after symptoms onset.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Municipal Health Commission

OTHER_GOV

Sponsor Role: collaborator

Capital Medical University

OTHER

Sponsor Role: collaborator

Suzhou First People's Hospital

UNKNOWN

Sponsor Role: collaborator

Linyi People's Hospital

OTHER

Sponsor Role: collaborator

Peking University Care Luzhong Hospital

OTHER

Sponsor Role: collaborator

Wuzhou Red Cross Hospital

OTHER

Sponsor Role: collaborator

Yantai Penglai Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role: collaborator

The First Affiliated Hospital of Hebei North University

OTHER

Sponsor Role: collaborator

Jiaozuo Tumor Hospital

UNKNOWN

Sponsor Role: collaborator

Hunan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

The People's Hospital of Liaoning Province

OTHER

Sponsor Role: collaborator

The First People's Hospital of Qujing, Yunnan Province

UNKNOWN

Sponsor Role: collaborator

Huizhou Third People's Hospital, Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Nanyang Nanshi Hospital, Henan University

UNKNOWN

Sponsor Role: collaborator

Xing'anmeng People's Hospital

UNKNOWN

Sponsor Role: collaborator

Beijing Aerospace Center Hospital

UNKNOWN

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiuhai Guo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Jialu Li, MD

Role: CONTACT

lijialu@ccmu.edu.cn

86-176-0074-2526

Xiuhai Guo, MD, PhD

Role: CONTACT

guoxhxuan@126.com

86-10-83198852

Facility Contacts

Xinya Wang

Role: primary

xwkyc@xwh.ccmu.edu.cn

86-10-83198852

Xiuhai Guo, MD, PhD

Role: primary

guoxhxuan@126.com

86-10-83198852

Other Identifiers

TIME-ICH

Identifier Type: -

Identifier Source: org_study_id