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

NCT04682951 | Completed

• 1 other identifier: 2020PI244
• Study Type: observational
• Target: 544
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Decompressive Craniectomy; Brain Injuries; Treatment Outcome

Keywords

Decompressive craniectomy; Outcome; Brain injuries; Aneurysmal subarachnoid hemorrhage; Cerebral venous thrombosis; Intracerebral hemorrhage; Ischemic stroke; Traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Decompressive Craniectomy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing a decompressive craniectomy on a 10 year period in CHRU Nancy, France.

You may qualify if:

• Patients undergoing a decompressive craniectomy from 06/11/2008 to 06/15/2018 in CHRU Nancy, France.

You may not qualify if:

• Infectious ou malignant disease leading to decompressive craniectomy.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

University Hospital of Nancy

Nancy, 54000, France

Location

MeSH Terms

Conditions

Brain Injuries; Subarachnoid Hemorrhage; Intracranial Thrombosis; Cerebral Hemorrhage; Ischemic Stroke; Brain Injuries, Traumatic

Interventions

Decompressive Craniectomy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Embolism and Thrombosis; Thromboembolism; Embolism and Thrombosis; Stroke

Intervention Hierarchy (Ancestors)

Decompression, Surgical; Surgical Procedures, Operative; Craniotomy; Neurosurgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: June 1, 2008
• Primary Completion: June 30, 2019
• Study Completion: December 1, 2020
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)