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| Name | Class |
|---|---|
| Beijing Municipal Science & Technology Commission | OTHER |
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The purpose of this study is to determine if computed tomography angiography can predict which individuals with intracerebral hemorrhage will experience significant growth in the size of the hemorrhage. For individuals who are at high risk for hemorrhage growth, the study will compare the drug Tranexamic acid to placebo to determine the effect and safety of on intracerebral hemorrhage growth
The Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign (TRAIGE) is a is a multicentre, randomized, placebo-controlled, double-blind, prospective, investigator-led, clinical trial of tranexamic acid within 6 hours of intracerebral hemorrhage in patients with contrast extravasation on CTA, 'the spot sign'. ICH patients within 6 hours of symptom onset, with the spot sign as a biomarker for ongoing hemorrhage, and no contraindications for antifibrinolytic therapy were enrolled in TRAIGE. The patient with a spot sign will be randomized to receive either the active treatment or placebo, the patient with no spot sign will be given regular treatment as observation. The trial is anticipated to complete in 36 months from the first subject recruitment , with 240 subjects recruited. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by IRB(Institutional Review Board) /EC(Ethics Committee) in Beijing Tiantan hospital, Capital Medical University.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tranexamic acid | Active Comparator | tranexamic acid |
|
| Placebo | Placebo Comparator | 0.9% NaCl |
|
| observation(spot sign -) | No Intervention | regular clinical treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| hemorrhage growth | either >33% or >6 ml increase from baseline, adjusted for baseline ICH volume | 24±2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Major thromboembolic events | (1) acute myocardial ischemia; (2) acute cerebral ischemia; and (3) acute pulmonary embolism | 30±4 days |
| Poor clinical outcome | The Number of patients that is Death or major disability(mRS 4-6) |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute ICH growth volume | The absolute ICH growth volume compared with the baseline CT scan | 24±2 hours |
| Absolute IVH growth volume | The absolute IVH growth volume compared with the baseline CT scan |
Inclusion Criteria:
Patients presenting with an acute spontaneous hypertensive Intracerebral hemorrhage
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liping Liu, MD | Contact | 8610-67098368 | lipingsister@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aviation General Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100050 | China | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37870112 | Derived | Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5. | |
| 30354984 | Derived |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 90±7 days |
| short-term outcome | The Number of patients that with Modified Rankin Scale (mRS) 0-2 at 30±4 days | 30±4 days |
| Other thromboembolic events | Other thromboembolic events,such as venous thrombosis and other peripheral arterial embolism | 90±7 days |
| Death due to any cause | Number of patients that is Death due to any cause by 90±7 days | 90±7 days |
| 24±2 hours |
| Beijing Fangshan District Liangxiang Hospital |
| Recruiting |
| Beijing |
| Beijing Municipality |
| 100050 |
| China |
| Beijing Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
| Beijing Haidian hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
| Beijing Huairou District Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100050 | China |
| Beijing Shunyi Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
| Beijing Tian Tan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
| Kailuan general hospital | Recruiting | Tangshan | Hebei | 063000 | China |
| Tangshan gongren hospital | Recruiting | Tangshan | Hebei | 063000 | China |
| Tangshan people's hospital | Recruiting | Tangshan | Hebei | 063000 | China |
| Fu F, Sun S, Liu L, Gu H, Su Y, Li Y. Iodine Sign as a Novel Predictor of Hematoma Expansion and Poor Outcomes in Primary Intracerebral Hemorrhage Patients. Stroke. 2018 Sep;49(9):2074-2080. doi: 10.1161/STROKEAHA.118.022017. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |