Brain Injuries Clinical Trial
Official title:
Good Prognosis Factors After Decompressive Craniectomy : a Ten-year Retrospective Study
| NCT number | NCT04682951 |
| Other study ID # | 2020PI244 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2008 |
| Est. completion date | December 1, 2020 |
| Verified date | December 2020 |
| Source | Central Hospital, Nancy, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Decompressive craniectomy is a treatment of refractory intracranial hypertension after various etiologies : malignant ischemic stroke, traumatic brain injury, intraparenchymal hemorrhage, aneurysmal subarachnoid hemorrhage, cerebral venous thrombosis. Initially considered as a lifesaving therapy, benefits in terms of survival were shown compared to medical treatment alone. However, despite a better survival, morbidity and poor neurological outcome are frequent among survivors. The objective of the study is to identify initial good neurological outcome factors after decompressive craniectomy in a large series of patients, in order to argue surgical and intensive care decisions, considering expected benefit and quality of life.
| Status | Completed |
| Enrollment | 544 |
| Est. completion date | December 1, 2020 |
| Est. primary completion date | June 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients undergoing a decompressive craniectomy from 06/11/2008 to 06/15/2018 in CHRU Nancy, France. Exclusion Criteria: - Infectious ou malignant disease leading to decompressive craniectomy. |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital of Nancy | Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Central Hospital, Nancy, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Good neurological outcome | The neurological outcome is considered "good" when Glasgow Outcome Score extended (GOSE) assessed 6 months after decompressive craniectomy is between 5 and 8. | 6 months after surgery |
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