Clinical trial NCT06760078: Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage
Official title: Safety and Efficacy of Intravenous Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Spontaneous Intracranial Hemorrhage
Hypertension
Keywords: Intracranial Hemorrhage
Tranexamic acid
Intensive blood pressure lowering
Haemostatic therapy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Health Commission
name: Capital Medical University
name: Suzhou First People's Hospital
name: Linyi People's Hospital
name: Peking University Care Luzhong Hospital
name: Wuzhou Red Cross Hospital
name: Yantai Penglai Traditional Chinese Medicine Hospital
name: The First Affiliated Hospital of Hebei North University
name: Jiaozuo Tumor Hospital
name: Hunan Provincial People's Hospital
name: The People's Hospital of Liaoning Province
name: The First People's Hospital of Qujing, Yunnan Province
name: Huizhou Third People's Hospital, Guangzhou Medical University
name: Nanyang Nanshi Hospital, Henan University
name: Xing'anmeng People's Hospital
name: Beijing Aerospace Center Hospital
First posted: 2025-01-06
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: modified Rankin Scale (mRS) of 0-3 at 90 days
timeFrame: 90 ± 7 days
Secondary outcomes:
measure: Hematoma expansion at 24 hours
timeFrame: 24±3 hours
measure: Absolute intracerebral haematoma growth at 24 hours
timeFrame: 24±3 hours
measure: Relative intracerebral haematoma growth at 24 hours
timeFrame: 24±3 hours
measure: Intraventricular hematoma (IVH) growth at 24 hours
timeFrame: 24±3 hours
measure: National Institutes of Health Stroke Scale (NIHSS) score at 24 hours
timeFrame: 24±3 hours
measure: Neurologic deterioration in first 24 hours
timeFrame: 24±3 hours
measure: Received surgical intervention within 7 days
timeFrame: Within 7±3 days
measure: modified Rankin Scale (mRS) score at 90 days
timeFrame: 90±7 days
measure: modified Rankin Scale (mRS) score of 0-4 at 90 days
timeFrame: 90±7 days
measure: Utility weighted modified Rankin Scale (mRS) score at 90 days
timeFrame: 90±7 days
measure: Major thromboembolic events
timeFrame: Within 90±7 days
measure: Death due to any cause within 90 days
timeFrame: Within 90±7 days
measure: Severe hypotension
timeFrame: Within 72 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xiuhai Guo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: