CraniectomyCHANCENCT04672785
Long-term Outcomes in Terms of Disability and Quality of Life for Patients Undergoing Posterior Cranial Fossa Craniectomy in the Context of Compressive Cerebellar Hematoma
An observational study of Craniectomy and Quality of Life, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Posterior cranial fossa craniectomy has been shown to improve patient survival. The level of autonomy, disability and quality of life of survivors has been little studied and still underresearched,. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Craniectomy, Quality of Life, Cerebellar Haematoma
- What is being tested?
- SF36 questionary
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2020to 12 May 2021
- 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: Every patients who underwent a posterior fossa craniectomy for a cerebellar hematoma at Grenoble University Hospital between 01/01/2010 and 01/01/2020
Who may be able to join
- Patient who underwent a posterior cranial fossa craniectomy in the context of an acute cerebellar hematoma between January 01, 2012 to January 01, 2020.
- Adult man or woman
- Hospitalized in intensive care
- No opposition from the patient or a loved one to a telephone contact to determine the SF36 (The Short Form) quality of life scale, from the medical outcome study.
Who cannot join
- Subject under guardianship or subject deprived of liberty
- Early limitation of active therapy before 48 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Posterior cranial fossa craniectomy has been shown to improve patient survival. The level of autonomy, disability and quality of life of survivors has been little studied and still underresearched,.
In this context, an assessment of the level of disability and of the quality of life after performing a posterior craniectomy seems relevant.
Read the detailed description
Investigators are carrying out a retrospective observational, single-center study, in three intensive care units in the Grenoble Hospital Center. Every patients who underwent a posterior fossa craniectomy for a cerebellar hematoma at Grenoble University Hospital between 01/01/2010 and 01/01/2020 were enrolled in this study. The main objective is to assess the level of disability and the quality of life of patients who have had a posterior cranial fossa craniectomy. The primary outcome is the mRS(Modified Rankin score) measured at least one year following the ICU discharge. Secondary outcomes are the mRS(Modified Rankin Score) measured at discharge from the rehabilitation department, the GOS (Glasgow Outcome score) measured at least one year following the discharge from intensive care, and the SF36 (The Short Form 36)from the medical outcome study, score assessing the quality of life, collected via phone call.
- Being tested
- SF36 questionary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SF36 questionaryBehavioural
patients who underwent a posterior fossa craniectomy for a cerebellar hematoma at Grenoble University Hospital between 01/01/2010 and 01/01/2020 were enrolled in this study. The main objective is to assess the level of disability and the quality of life of patients who have had a posterior cranial fossa craniectomy.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent a posterior fossa craniectomy for a cerebellar hematoma | Not described Receives: Behavioral: SF36 questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the level of handicap
The mRS (Modified Ranking score) measured at least one year following the ICU discharge during the consultation after hospitalization in the medical file
Measured: through study completion, an average of 1 years post admission
Secondary outcomes (2)
Global quality of life score
the SF36 score assessing the quality of life, collected via phone call.
Measured: from january 2020, during 6 months
Neurological recovery
the GOS (Glasgow Outcome Scale) score measured at least one year following the discharge from intensive care. It goes from 1 to 5.
1 corresponds to death 5.Good Recovery
Measured: from january 2020, during 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start17 Dec 2020
- Primary completion26 Feb 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniectomyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672785
- Sponsor's protocol ID
- 38RC20.355
- Other IDs
- 2020-A02717-32
- Acronym
- CHANCE
- Status last verified
- Apr 2021
- First submitted
- 11 Dec 2020
- Last updated
- 28 May 2021
- 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 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes in Terms of Disability and Quality of Life for Patients Undergoing Posterior Cranial Fossa Craniectomy in the Context of Compressive Cerebellar Hematoma
- ClinicalTrials.gov ID
- NCT04672785
- Acronym / sponsor ID
- CHANCE / 38RC20.355
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 17 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.
Posterior cranial fossa craniectomy has been shown to improve patient survival. The level of autonomy, disability and quality of life of survivors has been little studied and still underresearched,.
In this context, an assessment of the level of disability and of the quality of life after performing a posterior craniectomy seems relevant.
Detailed description
Investigators are carrying out a retrospective observational, single-center study, in three intensive care units in the Grenoble Hospital Center. Every patients who underwent a posterior fossa craniectomy for a cerebellar hematoma at Grenoble University Hospital between 01/01/2010 and 01/01/2020 were enrolled in this study. The main objective is to assess the level of disability and the quality of life of patients who have had a posterior cranial fossa craniectomy. The primary outcome is the mRS(Modified Rankin score) measured at least one year following the ICU discharge. Secondary outcomes are the mRS(Modified Rankin Score) measured at discharge from the rehabilitation department, the GOS (Glasgow Outcome score) measured at least one year following the discharge from intensive care, and the SF36 (The Short Form 36)from the medical outcome study, score assessing the quality of life, collected via phone call.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent a posterior fossa craniectomy for a cerebellar hematoma | – | Behavioral: SF36 questionary |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patients who underwent a posterior fossa craniectomy for a cerebellar hematoma at Grenoble University Hospital between 01/01/2010 and 01/01/2020
Key inclusion criteria (4 listed)
- Patient who underwent a posterior cranial fossa craniectomy in the context of an acute cerebellar hematoma between January 01, 2012 to January 01, 2020.
- Adult man or woman
- Hospitalized in intensive care
- No opposition from the patient or a loved one to a telephone contact to determine the SF36 (The Short Form) quality of life scale, from the medical outcome study.
Key exclusion criteria (2 listed)
- Subject under guardianship or subject deprived of liberty
- Early limitation of active therapy before 48 hours.
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 |
|---|---|---|
| SF36 questionarypatients who underwent a posterior fossa craniectomy for a cerebellar hematoma at Grenoble University Hospital between 01/01/2010 and 01/01/2020 were enrolled in this study. The main objective is to assess the level of disability and the quality of life of patients who have had a posterior cranial fossa craniectomy. | Behavioural | Patients who underwent a posterior fossa craniectomy for a cerebellar hematoma |
Primary outcome
Evaluate the level of handicap
Time frame: through study completion, an average of 1 years post admission
The mRS (Modified Ranking score) measured at least one year following the ICU discharge during the consultation after hospitalization in the medical file
2 secondary outcomes
Global quality of life score
Time frame: from january 2020, during 6 months
Neurological recovery
Time frame: from january 2020, during 6 months
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 28 May 2021.
- 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 Craniectomy and Quality of Life, run by University Hospital, Grenoble 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 4 inclusion and 2 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 28 May 2021. 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?
Evaluate the level of handicap (time frame: through study completion, an average of 1 years post admission). 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 28 May 2021.