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| Name | Class |
|---|---|
| Beijing Municipal Health Commission | OTHER_GOV |
| Capital Medical University | OTHER |
| Suzhou First People's Hospital | UNKNOWN |
| Linyi People's Hospital |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid (TXA) group | Experimental | Intravenous tranexamic acid 1 g over 10 minutes, followed by 1 g over 8 hours, with intensive blood pressure lowering. |
|
| Control group | Placebo Comparator | An intravenous placebo (normal saline) over 10 minutes, followed by another continuous infusion of placebo over 8 hours, with intensive blood pressure lowering maintained. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous tranexamic acid (TXA) infusion | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale (mRS) of 0-3 at 90 days | 90 ± 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hematoma expansion at 24 hours | The expansion is defined as a 33% or 6 mL increase from baseline hematoma volume or develop an intraventricular hemorrhage. | 24±3 hours |
| Absolute intracerebral haematoma growth at 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jialu Li, MD | Contact | 86-176-0074-2526 | lijialu@ccmu.edu.cn | |
| Xiuhai Guo, MD, PhD | Contact | 86-10-83198852 | guoxhxuan@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiuhai Guo, MD, PhD | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| OTHER |
| Peking University Care Luzhong Hospital | OTHER |
| Wuzhou Red Cross Hospital | OTHER |
| Yantai Penglai Traditional Chinese Medicine Hospital | OTHER |
| The First Affiliated Hospital of Hebei North University | OTHER |
| Jiaozuo Tumor Hospital | UNKNOWN |
| Hunan Provincial People's Hospital | OTHER |
| The People's Hospital of Liaoning Province | OTHER |
| The First People's Hospital of Qujing, Yunnan Province | UNKNOWN |
| Huizhou Third People's Hospital, Guangzhou Medical University | OTHER |
| Nanyang Nanshi Hospital, Henan University | UNKNOWN |
| Xing'anmeng People's Hospital | UNKNOWN |
| Beijing Aerospace Center Hospital | UNKNOWN |
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| Placebo | 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. |
|
| 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 | 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). | 24±3 hours |
| Received surgical intervention within 7 days | Interventions include hematoma evacuation, external ventricular drainage, and craniectomy. | Within 7±3 days |
| modified Rankin Scale (mRS) score at 90 days | 90±7 days |
| 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 | This includes ischemic stroke, myocardial infarction, and pulmonary embolism. | Within 90±7 days |
| Death due to any cause within 90 days | Within 90±7 days |
| Severe hypotension | Hypotension with clinical consequences (including acute renal failure) that required corrective therapy with intravenous fluids, vasopressors, or hemodialysis. | Within 72 hours |
| Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
|
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |