Malignant Middle Cerebral Artery InfarctionPhase 3DECIMALNCT00190203
Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts
A Phase 3 study testing Decompressive hemicraniectomy and duraplasty and hemicraniectomy in people with Malignant Middle Cerebral Artery Infarction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine if patients with malignant middle cerebral artery infarction have a better clinical outcome after early decompressive surgery compared to standard medical management. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Malignant Middle Cerebral Artery Infarction
- What is being tested?
- Decompressive hemicraniectomy and duraplasty and hemicraniectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2001to May 2006
- Phase
- Phase 3
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical and CT scan signs of complete infarction of the middle cerebral artery
- Onset of symptoms < 30 hours to a possible surgical intervention (< 24 hours for the inclusion and possibility to start treatment/surgery within 6 hours after randomisation)
- DWI infarct volume > 145 cm3
Who cannot join
- The patients having a neurological pre existing handicap (score of Rankin sup or equal in 2).
- Patients having an ischaemia lateral against significant.
- Patients having a haemorrhagic transformation(conversion) sup in 50 % of the territory of the infarct.
- Patients having a severe co-morbidity with a reduced life expectation.
- Patients having a severe cardio-respiratory co-morbidity.
- Patients having antecedent of DUROPLASTIE with transplant of dura mater or transplant of cornea.
Show all 12Show fewer
- Patients having a thrombolyses in 24 last hours.
- Patients having a severe coagulopathies.
- Patients having one against indication in the general anesthetic.
- Patients for whom a medical follow-up is not possible.
- The pregnant women.
- The patients to whom the surgical operation cannot be realized within 6 hours following the randomisation.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris
Paris, 75010
About this study
Official title: Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts : A Sequential Design, Multicenter, Randomized, Controlled Trial
The purpose of this study is to determine if patients with malignant middle cerebral artery infarction have a better clinical outcome after early decompressive surgery compared to standard medical management.
Read the detailed description
The Decompressive Craniectomy In MALignant middle cerebral artery infarction (DECIMAL) trial is a prospective, multicenter, randomized, open (single blind for the evaluation of the primary outcome measure) controlled study of the efficacy of decompressive craniectomy plus the standard medical therapy as compared with the standard medical therapy alone in patients with a malignant middle cerebral artery infarction. The study protocol is approved by a regional ethic committee (CCPPRB Hospital SAINT LOUIS, PARIS). The study is conducted in 13 stroke centers in France and is funded by the French Ministry of Health and the "ASSISTANCE PUBLIQUE- HOPITAUX DE PARIS". An independent Data Safety Monitoring Board (DSMB) monitors the safety, progress and ethics of the trial.
The aim of the trial is to determine if patients with malignant middle cerebral artery infarction have a better clinical outcome after early decompressive surgery compared to standard medical therapy alone.
Secondary objectives are to determine clinical or MRI based prognostic factors of better outcome after decompressive surgery.
- Being tested
- Decompressive hemicraniectomy and duraplasty, hemicraniectomy
- Keywords
- Malignant middle cerebral artery infarction, Decompressive surgery, Hemicraniectomy, Brain edema
- Medical subject headings
- Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompressive hemicraniectomy and duraplastyProcedure or surgery
Decompressive hemicraniectomy and duraplasty
hemicraniectomyProcedure or surgery
hemicraniectomy
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | HEMICRANIECTOMY Receives: Procedure: Decompressive hemicraniectomy and duraplasty; Procedure: hemicraniectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: Functional outcome at 6 months
Measured: at 6 months
Secondary outcomes (7)
Secondary endpoints:
Measured: during the study
Mortality
Measured: during the study
Functional outcome at 9 and 12 months (mRS, NIHSS, Barthel-index) after stroke
Measured: at 9 and 12 months and after stroke
Quality of life at 6 and 12 months (SIS)
Measured: at 6 and 12 months
Complications related to surgery
Measured: during the study
Infarct size at day 5-14 and week 12 and 48
Measured: at day 5-14 and week 12 and 48
Brainstem lesions on T2* after day 5-14 and week 12 and 48
Measured: after day 5-14 and week 12 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startDec 2001
- Primary completionMay 2006
- Study completionMay 2006
Why it stopped: the study is publiched
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Middle Cerebral Artery InfarctionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Katayoun VAHEDI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190203
- Sponsor's protocol ID
- P001004
- Other IDs
- AOM00148
- Acronym
- DECIMAL
- Status last verified
- Sep 2007
- First submitted
- 13 Sep 2005
- Last updated
- 17 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vahedi K, Hofmeijer J, Juettler E, Vicaut E, George B, Algra A, Amelink GJ, Schmiedeck P, Schwab S, Rothwell PM, Bousser MG, van der Worp HB, Hacke W; DECIMAL, DESTINY, and HAMLET investigators. Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials. Lancet Neurol. 2007 Mar;6(3):215-22. doi: 10.1016/S1474-4422(07)70036-4.
PubMed 17303527
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts : A Sequential Design, Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00190203
- Acronym / sponsor ID
- DECIMAL / P001004
- Keywords
- Malignant middle cerebral artery infarction, Decompressive surgery, Hemicraniectomy, Brain edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study is publiched
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2001
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 19 Sep 2005 (estimated)
- 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.
The purpose of this study is to determine if patients with malignant middle cerebral artery infarction have a better clinical outcome after early decompressive surgery compared to standard medical management.
Detailed description
The Decompressive Craniectomy In MALignant middle cerebral artery infarction (DECIMAL) trial is a prospective, multicenter, randomized, open (single blind for the evaluation of the primary outcome measure) controlled study of the efficacy of decompressive craniectomy plus the standard medical therapy as compared with the standard medical therapy alone in patients with a malignant middle cerebral artery infarction. The study protocol is approved by a regional ethic committee (CCPPRB Hospital SAINT LOUIS, PARIS). The study is conducted in 13 stroke centers in France and is funded by the French Ministry of Health and the "ASSISTANCE PUBLIQUE- HOPITAUX DE PARIS". An independent Data Safety Monitoring Board (DSMB) monitors the safety, progress and ethics of the trial.
The aim of the trial is to determine if patients with malignant middle cerebral artery infarction have a better clinical outcome after early decompressive surgery compared to standard medical therapy alone.
Secondary objectives are to determine clinical or MRI based prognostic factors of better outcome after decompressive surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Decompressive hemicraniectomy and duraplasty, Procedure: hemicraniectomyHEMICRANIECTOMY |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical and CT scan signs of complete infarction of the middle cerebral artery
- Onset of symptoms < 30 hours to a possible surgical intervention (< 24 hours for the inclusion and possibility to start treatment/surgery within 6 hours after randomisation)
- DWI infarct volume > 145 cm3
Key exclusion criteria (12 listed)
- The patients having a neurological pre existing handicap (score of Rankin sup or equal in 2).
- Patients having an ischaemia lateral against significant.
- Patients having a haemorrhagic transformation(conversion) sup in 50 % of the territory of the infarct.
- Patients having a severe co-morbidity with a reduced life expectation.
- Patients having a severe cardio-respiratory co-morbidity.
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 hemicraniectomy and duraplastyDecompressive hemicraniectomy and duraplasty | Procedure or surgery | A |
| hemicraniectomyhemicraniectomy | Procedure or surgery | A |
Primary outcome
Primary endpoint: Functional outcome at 6 months
Time frame: at 6 months
7 secondary outcomes
Secondary endpoints:
Time frame: during the study
Mortality
Time frame: during the study
Functional outcome at 9 and 12 months (mRS, NIHSS, Barthel-index) after stroke
Time frame: at 9 and 12 months and after stroke
Quality of life at 6 and 12 months (SIS)
Time frame: at 6 and 12 months
Complications related to surgery
Time frame: during the study
Infarct size at day 5-14 and week 12 and 48
Time frame: at day 5-14 and week 12 and 48
Brainstem lesions on T2* after day 5-14 and week 12 and 48
Time frame: after day 5-14 and week 12 and 48
Results and safety
The study was stopped early (reason given: the study is publiched). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2008.
- Results publication: PubMed 17303527Vahedi K, Hofmeijer J, Juettler E, Vicaut E, George B, Algra A, Amelink GJ, Schmiedeck P, Schwab S, Rothwell PM, Bousser MG, van der Worp HB, Hacke W; DECIMAL, DESTINY, and HAMLET investigators. Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials. Lancet Neurol. 2007 Mar;6(3):215-22. doi: 10.1016/S1474-4422(07)70036-4.
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.
Katayoun VAHEDI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Decompressive hemicraniectomy and duraplasty and hemicraniectomy in people with Malignant Middle Cerebral Artery Infarction, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 17 Jan 2008. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: the study is publiched). Results are not available in the source record.
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?
Primary endpoint: Functional outcome at 6 months (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00190203, which also lists 1 linked publication.
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 17 Jan 2008.