Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05542108 - Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants N/A
Completed NCT03400904 - Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome.
Completed NCT06073145 - Transcranial Doppler Using Wearable Ultrasound Patch
Recruiting NCT03899532 - Remote Ischemic Conditioning in Traumatic Brain Injury N/A
Recruiting NCT06010823 - Safety and Efficacy Evaluation of the Robotic Enhanced Error Training of Upper Limb Function in Post-stroke and Post TBI Participants N/A
Not yet recruiting NCT05833568 - Five-day 20-minute 10-Hz tACS in Patients With a Disorder of Consciousness N/A
Withdrawn NCT04288076 - The Brain and Lung Interaction (BALI) Study N/A
Completed NCT03162484 - Physical Activity and Chronic Acquired Brain Injury N/A
Not yet recruiting NCT02756585 - Computed Tomography Perfusion in Patients With Severe Head Injury N/A
Terminated NCT01430988 - Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury N/A
Completed NCT01093053 - Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations N/A
Completed NCT00975338 - The LETS Study: A Longitudinal Evaluation of Transition Services
Completed NCT00878631 - Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline Phase 2/Phase 3
Completed NCT03166722 - Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition N/A
Not yet recruiting NCT04478812 - Tbit System Precision and Correlation of Different Blood Samples N/A
Recruiting NCT05443542 - VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI N/A
Recruiting NCT05309005 - Virtual Reality and Social Cognition After Acquired Brain Injury
Completed NCT02702635 - Measuring Blood Flow Characteristics Using Dynamic Contrast Enhanced Magnetic Resonance Imaging N/A
Withdrawn NCT04247321 - Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure N/A
Not yet recruiting NCT04386525 - Omega 3 and Ischemic Stroke; Fish Oil as an Option Phase 4