Cerebral HerniationNCT04555460
Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction
A study testing Hemicraniectomy and Conservative medical therapy in people with Cerebral Herniation, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This trial is a prospective, randomized, controlled, clinical trial based on a stroke center. We randomly assigned 151 patients 41 years of age or older (median, 65 years; range, 41 to 83) with malignant middle cerebral artery infarction to either conservative medical treatment or hemicraniectomy; assignments were… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cerebral Herniation
- What is being tested?
- Hemicraniectomy and Conservative medical therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2003to 30 Dec 2008
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A National Institutes of Health Stroke Scale score ≥16
- A score ≥1 for item 1a (level of consciousness)
- Brain computed tomography ischemic signs involving 2/3 of the middle cerebral artery territory
- Diffusion-weighted imaging infarct volume >150cm3
Who cannot join
- Prestroke modified Rankin score score ≥2
- Prestroke score on the Barthel Index <95
- Score on the Glasgow Coma Scale <6
- Both pupils fixed and dilated
- Any other coincidental brain lesion that might affect outcome
- Plasminogen activator in the 12 h before randomisation
Show all 12Show fewer
- Space-occupying hemorrhagic transformation of the infarct
- Pregnancy
- Life expectancy <3 years
- Other serious illness that might affect outcome
- Known coagulopathy or systemic bleeding disorder
- Contraindication for anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction: A Randomized, Controlled Study
This trial is a prospective, randomized, controlled, clinical trial based on a stroke center. We randomly assigned 151 patients 41 years of age or older (median, 65 years; range, 41 to 83) with malignant middle cerebral artery infarction to either conservative medical treatment or hemicraniectomy; assignments were made within 12 to 38 hours after the onset of symptoms. The primary end point was survival with slight or moderate disability 12 months after randomization (defined by a score of 0 to 3 on the modified Rankin scale, which ranges from 0 [no symptoms] to 6 [death]). Secondary outcome included death, Barthel Index, National Institute of Health Stroke Scale, and Stroke Impact Scale 2.0 (SIS) 6 months and 1 year after randomization. Variables for subgroup analyses were age, sex, presence of aphasia or neglect, stroke severity and time to randomization. The study was performed according to Consolidated Standards of Reporting Trials (CONSORT).
Read the detailed description
Patients between 40 to 80 years of age were included within 12 to 38 hours of a malignant middle cerebral artery infarction defined by the association of 3 criteria: a National Institutes of Health Stroke Scale score ≥16, including a score ≥1 for item 1a (level of consciousness); brain computed tomography ischemic signs involving 2/3 of the middle cerebral artery territory; and a diffusion-weighted imaging (DWI) infarct volume >150cm3. The first patient was enrolled in January 2003 and the last patient in December 2007. An independent data safety monitoring committee monitored the safety, progress, and ethics of the trial. Patients were randomized to either surgical plus medical treatment or to conservative medical treatment alone.
- Conditions
- Cerebral Herniation
- Being tested
- Hemicraniectomy, Conservative medical therapy
- Keywords
- infarction, hemicraniectomy
- Medical subject headings
- Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemicraniectomyProcedure or surgery
Also called Surgical decompression
Large hemicraniectomy and duraplasty
Conservative medical therapyOther
Also called Control group
Conservative medical therapy was based on published guidelines for the early management of patients with ischemic stroke
| Study group | Role | What they receive |
|---|---|---|
| Decompressive surgery | Active comparator | Decompressive surgery was performed with a large hemicraniectomy that removed, ipsilateral to the stroke, a bone flap as large as possible including temporal, frontal, parietal, and some occipital squama. Receives: Procedure: Hemicraniectomy |
| Conservative medical therapy | Active comparator | Conservative medical therapy was based on published guidelines for the early management of patients with ischemic stroke. Administration of intravenous mannitol (0.25 to 0.5 g/kg) or furosemide was given only in patients whose condition was rapidly worsening because of brain edema, without additional recommendations on loading doses. Receives: Other: Conservative medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin score 0-3
Slight or moderate disability 12 months after randomization (defined by a score of 0 to 3 on the modified Rankin scale
Measured: 1 year
Secondary outcomes (4)
Death
Death at 6 month and 1 year
Measured: 1 year
Barthel Index
measured12 months after randomization (defined by a score of 0 to 100; as 100 being the best)
Measured: 1 year
National Institute of Health Stroke Scale (NIHSS)
measured12 months after randomization (The maximum possible score is 42, with the minimum score being a 0)
Measured: 1 year
Stroke Impact Scale 2.0 (SIS)
The score of each domain was calculated as 100 being the best, with a range of 0-100.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start23 Jan 2003
- Primary completion30 Dec 2007
- Study completion30 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral HerniationStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Emre Kumral, Ege University
- Investigators
- Timur Köse, PhD, Principal investigator, Biostatistic Department, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555460
- Sponsor's protocol ID
- 2003/44
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 3 months after publication data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction: A Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT04555460
- Acronym / sponsor ID
- 2003/44
- Conditions
- Cerebral Herniation
- Keywords
- infarction, hemicraniectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 23 Jan 2003 (actual)
- Primary completion
- 30 Dec 2007 (actual)
- Study completion
- 30 Dec 2008 (actual)
- First posted
- 18 Sep 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.
This trial is a prospective, randomized, controlled, clinical trial based on a stroke center. We randomly assigned 151 patients 41 years of age or older (median, 65 years; range, 41 to 83) with malignant middle cerebral artery infarction to either conservative medical treatment or hemicraniectomy; assignments were made within 12 to 38 hours after the onset of symptoms. The primary end point was survival with slight or moderate disability 12 months after randomization (defined by a score of 0 to 3 on the modified Rankin scale, which ranges from 0 [no symptoms] to 6 [death]). Secondary outcome included death, Barthel Index, National Institute of Health Stroke Scale, and Stroke Impact Scale 2.0 (SIS) 6 months and 1 year after randomization. Variables for subgroup analyses were age, sex, presence of aphasia or neglect, stroke severity and time to randomization. The study was performed according to Consolidated Standards of Reporting Trials (CONSORT).
Detailed description
Patients between 40 to 80 years of age were included within 12 to 38 hours of a malignant middle cerebral artery infarction defined by the association of 3 criteria: a National Institutes of Health Stroke Scale score ≥16, including a score ≥1 for item 1a (level of consciousness); brain computed tomography ischemic signs involving 2/3 of the middle cerebral artery territory; and a diffusion-weighted imaging (DWI) infarct volume >150cm3. The first patient was enrolled in January 2003 and the last patient in December 2007. An independent data safety monitoring committee monitored the safety, progress, and ethics of the trial. Patients were randomized to either surgical plus medical treatment or to conservative medical treatment alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decompressive surgery | Active comparator | Procedure: HemicraniectomyDecompressive surgery was performed with a large hemicraniectomy that removed, ipsilateral to the stroke, a bone flap as large as possible including temporal, frontal, parietal, and some occipital squama. |
| Conservative medical therapy | Active comparator | Other: Conservative medical therapyConservative medical therapy was based on published guidelines for the early management of patients with ischemic stroke. Administration of intravenous mannitol (0.25 to 0.5 g/kg) or furosemide was given only in patients whose condition was rapidly worsening because of brain edema, without additional recommendations on loading doses. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A National Institutes of Health Stroke Scale score ≥16
- A score ≥1 for item 1a (level of consciousness)
- Brain computed tomography ischemic signs involving 2/3 of the middle cerebral artery territory
- Diffusion-weighted imaging infarct volume >150cm3
Key exclusion criteria (12 listed)
- Prestroke modified Rankin score score ≥2
- Prestroke score on the Barthel Index <95
- Score on the Glasgow Coma Scale <6
- Both pupils fixed and dilated
- Any other coincidental brain lesion that might affect outcome
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 |
|---|---|---|
| HemicraniectomyAlso: Surgical decompressionLarge hemicraniectomy and duraplasty | Procedure or surgery | Decompressive surgery |
| Conservative medical therapyAlso: Control groupConservative medical therapy was based on published guidelines for the early management of patients with ischemic stroke | Other | Conservative medical therapy |
Primary outcome
modified Rankin score 0-3
Time frame: 1 year
Slight or moderate disability 12 months after randomization (defined by a score of 0 to 3 on the modified Rankin scale
4 secondary outcomes
Death
Time frame: 1 year
Barthel Index
Time frame: 1 year
National Institute of Health Stroke Scale (NIHSS)
Time frame: 1 year
Stroke Impact Scale 2.0 (SIS)
Time frame: 1 year
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 18 Sep 2020.
- Individual participant dataSharing planned: No. 3 months after publication data will be shared
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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.
Timur Köse, PhD principal investigator
Biostatistic Department, Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemicraniectomy and Conservative medical therapy in people with Cerebral Herniation, run by Ege University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 18 Sep 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 Turkey (Türkiye). 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?
modified Rankin score 0-3 (time frame: 1 year). 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 18 Sep 2020.