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| Name | Class |
|---|---|
| Xingguo County People's Hospital | UNKNOWN |
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Intracerebral hemorrhage (ICH) is a devastating disease with high early mortality, unfavorable neurological outcomes, and high cost of care. To date, the role of DTI-guided minimally invasive hematoma evacuation in ICH is still uncertain.
The investigators will conduct a multicenter randomized controlled trial, as well as a concurrent prospective observational study including all ICH patients who decline participation in the trial and will therefore receive minimally invasive hematoma evacuation or best medical therapy and consent to be followed up. All participants will be followed up at the same time using the same outcomes measures. The primary outcome will be collected by a blinded assessor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally Invasive Hematoma Evacuation | Experimental | Subjects randomized to this arm will receive the intervention of minimally invasive hematoma evacuation and best medical therapy |
|
| Best Medical Therapy | Active Comparator | Subjects randomized to this arm will receive best medical therapy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally Invasive Hematoma Evacuation | Procedure | Procedure of minimally invasive hematoma evacuation PLUS best medical therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of score of 0-3 on the modified Rankin scale | Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability. | 180 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Score of on the modified Rankin scale | Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability. | 180 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic intracranial hemorrhage | Symptomatic intracranial hemorrhage will be defined according the Heidelberg bleeding classification criteria | 30 days after randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongming Qiu | Contact | +8613236599269 | qiuzhongmingdoctor@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xingguo County People's Hospital | Recruiting | Ganzhou | Jiangxi | China |
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| ID | Term |
|---|---|
| D000083302 | Hemorrhagic Stroke |
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Other design features: The investigators will conduct a multicenter randomized controlled trial, as well as a concurrent prospective observational study including all ICH patients who decline participation in the trial and will therefore receive minimally invasive hematoma evacuation or best medical therapy and consent to be followed up. All participants will be followed up at the same time using the same outcomes measures. The primary outcome will be collected by a blinded assessor.
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| Best Medical Therapy | Other | Best medical therapy |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |