Decompressive CraniectomyNCT04682951
Good Prognosis Factors After Decompressive Craniectomy : a Ten-year Retrospective Study
An observational study of Decompressive Craniectomy and Brain Injuries, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompressive Craniectomy, Brain Injuries, Treatment Outcome
- What is being tested?
- Decompressive Craniectomy
- Type of treatment
- Surgery or procedure
- How many people
- 544 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing a decompressive craniectomy on a 10 year period in CHRU Nancy, France.
Who may be able to join
- Patients undergoing a decompressive craniectomy from 06/11/2008 to 06/15/2018 in CHRU Nancy, France.
Who cannot join
- Infectious ou malignant disease leading to decompressive craniectomy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Decompressive Craniectomy
- Keywords
- Decompressive craniectomy, Outcome, Brain injuries, Aneurysmal subarachnoid hemorrhage, Cerebral venous thrombosis, Intracerebral hemorrhage, Ischemic stroke, Traumatic brain injury
- Medical subject headings
- Brain Injuries, Subarachnoid Hemorrhage, Intracranial Thrombosis, Cerebral Hemorrhage, Ischemic Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompressive CraniectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study startJun 2008
- Primary completion30 Jun 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompressive CraniectomyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AUDIBERT Gérard, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682951
- Sponsor's protocol ID
- 2020PI244
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Good Prognosis Factors After Decompressive Craniectomy : a Ten-year Retrospective Study
- ClinicalTrials.gov ID
- NCT04682951
- Acronym / sponsor ID
- 2020PI244
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 544 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jun 2008 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing a decompressive craniectomy on a 10 year period in CHRU Nancy, France.
Key inclusion criteria (1 listed)
- Patients undergoing a decompressive craniectomy from 06/11/2008 to 06/15/2018 in CHRU Nancy, France.
Key exclusion criteria (1 listed)
- Infectious ou malignant disease leading to decompressive craniectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decompressive Craniectomy | Procedure or surgery | – |
Primary outcome
Good neurological outcome
Time frame: 6 months after surgery
The neurological outcome is considered "good" when Glasgow Outcome Score extended (GOSE) assessed 6 months after decompressive craniectomy is between 5 and 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decompressive Craniectomy and Brain Injuries, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good neurological outcome (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.