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Decompressive craniectomy has been reported for the treatment of patients with intracerebral hemorrhage. But no prospective randomised controlled trials have yet been undertaken to confirm its effect.The purpose of the study is to determine whether decompressive craniectomy post hematoma removal surgery after intracerebral hemorrhage will reduce the chances of a person dying or surviving with a long term disability.
Intracerebral hemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Hematoma removal (HR) surgery is the primary treatment for ICH which volume is more than 30ml. But whether decompressive craniectomy (DC) should be employed during the HR surgery still has considerable controversy. Outcomes in this study will be measured at 3 months after surgery via a postal questionnaire including the Glasgow Outcome scale, Modified Rankin Scale, and Barthel index. Two hundred patients will be recruited to the trial over 36 months. Follow-up will take three months with analysis and reporting taking one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decompressive Craniectomy | Experimental | Decompressive Craniectomy afte Hematoma Removal in Patients with Intracerebral Hemorrhage |
|
| non-Decompressive Craniectomy | Active Comparator | non-Decompressive Craniectomy afte Hematoma Removal in Patients with Intracerebral Hemorrhage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decompressive Craniectomy | Procedure | A portion of frontal,temporal, and parietal bone was removed by craniectomy and the size of decompression was about 10x12 cm2.Intracerebral hematoma was evacuated by transcortical approach with the aid of a surgical microscope. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality and disability | according to a 3-6 scores on the modified Rankin Score | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of second Surgery | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rong Hu, MD,PhD | Department of Neurosurgery, Southwest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery , Southwest Hospital, Third Military Medical University, | Recruiting | Chongqing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38640513 | Derived | Zhang C, Zhang S, Yin Y, Wang L, Li L, Lan C, Shi J, Jiang Z, Ge H, Li X, Ao Z, Hu S, Chen J, Feng H, Hu R. Clot removAl with or without decompRessive craniectomy under ICP monitoring for supratentorial IntraCerebral Hemorrhage (CARICH): a randomized controlled trial. Int J Surg. 2024 Aug 1;110(8):4804-4809. doi: 10.1097/JS9.0000000000001466. | |
| 32514905 |
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| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D056424 | Decompressive Craniectomy |
| ID | Term |
|---|---|
| D019299 | Decompression, Surgical |
| D013514 | Surgical Procedures, Operative |
| D003399 | Craniotomy |
| D019635 | Neurosurgical Procedures |
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| non-Decompressive Craniectomy | Procedure | a simple hematoma removal by osteoplastic craniotomy group (HR) or Intracerebral hematoma was evacuated by transcortical approach with the aid of a surgical neuroendoscopyand the size of decompression was about 3x2.5 cm2. |
|
| Hu R, Zhang C, Xia J, Ge H, Zhong J, Fang X, Zou Y, Lan C, Li L, Feng H. Long-term Outcomes and Risk Factors Related to Hydrocephalus After Intracerebral Hemorrhage. Transl Stroke Res. 2021 Feb;12(1):31-38. doi: 10.1007/s12975-020-00823-y. Epub 2020 Jun 8. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |