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NCT04682951 Clinical Trial

Good Prognosis Factors After Decompressive Craniectomy : a Ten-year Retrospective Study

Brain Injuries Clinical Trial

Official title:
Good Prognosis Factors After Decompressive Craniectomy : a Ten-year Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date December 2020
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Decompressive Craniectomy

Locations
Country Name City State
France University Hospital of Nancy Nancy

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
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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