Stroke, IschemicNCT06489470
Strokectomy in Malignant Cerebral Media Infarction
A study testing Strokectomy/Necrosectomy in people with Stroke, Ischemic, run by University of Rostock at 1 site in Germany.
Trial summary
Decompressive hemicraniectomy (DC) is the standard procedure and life saving measure in case of malignant middle cerebral artery (MCA) infarction. However, there have been several studies reporting the neuroinflammatory cascade based on the necrotic tissue as one of the leading cause for the secondary brain damage… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Strokectomy/Necrosectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jun 2024to 30 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Ischemic middle cerebral artery (MCA) infarction at least two thirds of the MCA territory
- Clinical symptoms of acute unilateral MCA infarction less than 48 hours prior to the initiation of treatment
Who cannot join
- Preexisting modified Rankin Scale >2
- Absence of pupillary reflexes or GCS <6
- Intracerebral hemorrhage or other associated brain lesions
- Contraindications for surgery
- Estimated life expectancy of less than 3 years
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Rostock
Rostock, Mecklenburg-Vorpommern, 18057
Sae-Yeon Won, 0381 494 146067, sae-yeon.won@med.uni-rostock.de
About this study
Official title: Strokectomy in Malignant Cerebral Media Infarction: A Pilot Study
Decompressive hemicraniectomy (DC) is the standard procedure and life saving measure in case of malignant middle cerebral artery (MCA) infarction. However, there have been several studies reporting the neuroinflammatory cascade based on the necrotic tissue as one of the leading cause for the secondary brain damage, wherefore, strokectomy with resection of necrotic tissue has been proposed in some case series as an alternative surgical option. Thus, the aim of this study is to perform a pilot study by including patients with malignant MCA infarction and to check the feasibility of this specific surgical treatment.
Read the detailed description
Ischemic stroke is one of the leading causes of disability and death worldwide. While cerebral middle cerebral artery (MCA) infarction constitutes approximately 10% of all ischemic, it is a life-threatening medical emergency causing a mass effect with substantial rise in intracranial pressure and reduction of cerebral blood flow. The letality of malignant MCA-infarction under conservative treatment lies around 70%, wherefore a surgical treatment is important in these patients. In the past years, there have been several randomized controlled trials (DESTINY, DECIMAL, HAMLET) focussing on the decompressive hemicraniectomy (DC) in malignant MCA infarction. Those studies have shown the superiority of DC compared to medical management in higher rate of survival and favorable outcome measured by modified Rankin Scale (mRS). Consequently, the DC is recommended as a life-saving treatment in the American Stoke Association for patients under 60 years of age. Further, the DESTINY II trial could show the beneficial effect of DC in patients over 60 years of age as well, wherefore the age alone is not a cut-off line anymore to indicate a surgical treatment.
Despite this life saving measure, there are several sequelae of DC to consider. Patients who have survived usually undergo a second surgery to close the skull defect by cranioplasty. As previous study reported, the surgical procedure of cranioplasty inherits a high complication rate up to 34% including infection, wound impairment, intracranial hemorrhage and aseptic necrosis. Further, DC can cause a syndrome of the trephined or hydrocephalus which is associated with additional risk for patient and increased cost for the community.
Recently, investigator´s research group performed a multicentric study across academic hospitals in Germany including over 500 patients with cerebellar infarction. As a subgroup analysis, investigators compared the functional outcome in these cohorts considering different surgical treatment strategies: craniotomy+necrosectomy versus DC. According to this study, craniotomy + necrosectomy was superior in higher rate of favorable outcome at discharge and at 3 months follow-up compared to DC. This result is supported by a recent systematic review and meta-analysis by Ayling et al. as well. In line with this, resection of infarcted frontal/temporal lobe has been proposed as surgical alternative to DC in malignant MCA-infarction (defined as "strokectomy", "necrosectomy"). In a recent systematic review and meta analysis, there was a clear trend towards higher favorable outcome in necrosectomy group compared to DC group (mRS 0-3: 58.5% vs 39.4%) with malignant MCA-infarction, however, further clinical studies are needed for more evidence concerning the specific surgical method to integrate in the clinical routine.
Pathophysiologically, it has been shown that the neuroinflammatory cascade ensue during ischemic stroke. Experimental and clinical studies support the existence of inflammatory area surround the initial lesion in the subacute phase of ischemic stroke, which was defined as "inflammatory penumbra". Cellar death occurs in this region with triggering cytotoxic T-cells resulting in increased cell death and cytotoxic edema. This phenomenon might have contributed to the superior functional results observed in the necrosectomy group in ischemic stroke, but this hypothesis has to be proved in the future studies.
Thus, the general aims are to evaluate the functional outcome of malignant MCA-infarction treated either by necrosectomy or DC in an international, multicentric large cohort of patients. Prior to this study, the aim of current study is to perform a pilot study performing necrosectomy in malignant MCA-infarction to proof the feasibility of the intervention.
- Conditions
- Stroke, Ischemic
- Being tested
- Strokectomy/Necrosectomy
- Keywords
- necrosectomy, alternative surgical treatment, strokectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strokectomy/NecrosectomyProcedure or surgery
After obtaining CT-/MRT-perfusion, the infarcted area (e.g. infarct core) of malignant MCA-infarction is localized. By using the neuronavigation, surgical resection of necrotic tissue is performed in a non-eloquent area until the space occupying effect is released. At the end of the surgery, the bone flap is reinserted and fixated.
| Study group | Role | What they receive |
|---|---|---|
| Necrosectomy/Strokectomy | Experimental | Not described Receives: Procedure: Strokectomy/Necrosectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of resurgery after necrosectomy of malignant MCA-infarction
After the surgical treatment, the patients will be treated in the neurointensive care unit. During the clinical course, the necessity to perform a secondary surgery (e.g. hemicraniectomy) will be observed. For the safety of the patients, intracranial pressure monitoring will be continously performed as well.
Measured: up to 2 weeks
Secondary outcomes (2)
Surgical complications
The rate of wound infection, other infections, postoperative hemorrhage and postoperative seizure will be documented during the clinical course and follow-up.
Measured: up to 3 months
Functional outcome via modified Rankin Scale (mRS; range 0-6; 0-3: favorable outcome, 4-6: unfavorable outcome) at 3 months
After 3 months, the functional outcome will be evaluated by modified Rankin Scale.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start15 Jun 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sae-Yeon Won, University of Rostock
- Investigators
- Sae-Yeon Won, MD, Principal investigator, Neurosurgery, University Medical Center RostockFlorian Gessler, MD PhD, Study director, Neurosurgery, University Medical Center RostockMatthias Wittstock, MD, Study chair, Neurology, University Medical Center Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489470
- Sponsor's protocol ID
- UMR1
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strokectomy in Malignant Cerebral Media Infarction: A Pilot Study
- ClinicalTrials.gov ID
- NCT06489470
- Acronym / sponsor ID
- UMR1
- Conditions
- Stroke, Ischemic
- Keywords
- necrosectomy, alternative surgical treatment, strokectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 8 Jul 2024 (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 hemicraniectomy (DC) is the standard procedure and life saving measure in case of malignant middle cerebral artery (MCA) infarction. However, there have been several studies reporting the neuroinflammatory cascade based on the necrotic tissue as one of the leading cause for the secondary brain damage, wherefore, strokectomy with resection of necrotic tissue has been proposed in some case series as an alternative surgical option. Thus, the aim of this study is to perform a pilot study by including patients with malignant MCA infarction and to check the feasibility of this specific surgical treatment.
Detailed description
Ischemic stroke is one of the leading causes of disability and death worldwide. While cerebral middle cerebral artery (MCA) infarction constitutes approximately 10% of all ischemic, it is a life-threatening medical emergency causing a mass effect with substantial rise in intracranial pressure and reduction of cerebral blood flow. The letality of malignant MCA-infarction under conservative treatment lies around 70%, wherefore a surgical treatment is important in these patients. In the past years, there have been several randomized controlled trials (DESTINY, DECIMAL, HAMLET) focussing on the decompressive hemicraniectomy (DC) in malignant MCA infarction. Those studies have shown the superiority of DC compared to medical management in higher rate of survival and favorable outcome measured by modified Rankin Scale (mRS). Consequently, the DC is recommended as a life-saving treatment in the American Stoke Association for patients under 60 years of age. Further, the DESTINY II trial could show the beneficial effect of DC in patients over 60 years of age as well, wherefore the age alone is not a cut-off line anymore to indicate a surgical treatment.
Despite this life saving measure, there are several sequelae of DC to consider. Patients who have survived usually undergo a second surgery to close the skull defect by cranioplasty. As previous study reported, the surgical procedure of cranioplasty inherits a high complication rate up to 34% including infection, wound impairment, intracranial hemorrhage and aseptic necrosis. Further, DC can cause a syndrome of the trephined or hydrocephalus which is associated with additional risk for patient and increased cost for the community.
Recently, investigator´s research group performed a multicentric study across academic hospitals in Germany including over 500 patients with cerebellar infarction. As a subgroup analysis, investigators compared the functional outcome in these cohorts considering different surgical treatment strategies: craniotomy+necrosectomy versus DC. According to this study, craniotomy + necrosectomy was superior in higher rate of favorable outcome at discharge and at 3 months follow-up compared to DC. This result is supported by a recent systematic review and meta-analysis by Ayling et al. as well. In line with this, resection of infarcted frontal/temporal lobe has been proposed as surgical alternative to DC in malignant MCA-infarction (defined as "strokectomy", "necrosectomy"). In a recent systematic review and meta analysis, there was a clear trend towards higher favorable outcome in necrosectomy group compared to DC group (mRS 0-3: 58.5% vs 39.4%) with malignant MCA-infarction, however, further clinical studies are needed for more evidence concerning the specific surgical method to integrate in the clinical routine.
Pathophysiologically, it has been shown that the neuroinflammatory cascade ensue during ischemic stroke. Experimental and clinical studies support the existence of inflammatory area surround the initial lesion in the subacute phase of ischemic stroke, which was defined as "inflammatory penumbra". Cellar death occurs in this region with triggering cytotoxic T-cells resulting in increased cell death and cytotoxic edema. This phenomenon might have contributed to the superior functional results observed in the necrosectomy group in ischemic stroke, but this hypothesis has to be proved in the future studies.
Thus, the general aims are to evaluate the functional outcome of malignant MCA-infarction treated either by necrosectomy or DC in an international, multicentric large cohort of patients. Prior to this study, the aim of current study is to perform a pilot study performing necrosectomy in malignant MCA-infarction to proof the feasibility of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Necrosectomy/Strokectomy | Experimental | Procedure: Strokectomy/Necrosectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Ischemic middle cerebral artery (MCA) infarction at least two thirds of the MCA territory
- Clinical symptoms of acute unilateral MCA infarction less than 48 hours prior to the initiation of treatment
Key exclusion criteria (5 listed)
- Preexisting modified Rankin Scale >2
- Absence of pupillary reflexes or GCS <6
- Intracerebral hemorrhage or other associated brain lesions
- Contraindications for surgery
- Estimated life expectancy of less than 3 years
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 |
|---|---|---|
| Strokectomy/NecrosectomyAfter obtaining CT-/MRT-perfusion, the infarcted area (e.g. infarct core) of malignant MCA-infarction is localized. By using the neuronavigation, surgical resection of necrotic tissue is performed in a non-eloquent area until the space occupying effect is released. At the end of the surgery, the bone flap is reinserted and fixated. | Procedure or surgery | Necrosectomy/Strokectomy |
Primary outcome
Rate of resurgery after necrosectomy of malignant MCA-infarction
Time frame: up to 2 weeks
After the surgical treatment, the patients will be treated in the neurointensive care unit. During the clinical course, the necessity to perform a secondary surgery (e.g. hemicraniectomy) will be observed. For the safety of the patients, intracranial pressure monitoring will be continously performed as well.
2 secondary outcomes
Surgical complications
Time frame: up to 3 months
Functional outcome via modified Rankin Scale (mRS; range 0-6; 0-3: favorable outcome, 4-6: unfavorable outcome) at 3 months
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: Yes
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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.
Sae-Yeon Won, MD principal investigator
Neurosurgery, University Medical Center Rostock
Florian Gessler, MD PhD study director
Neurosurgery, University Medical Center Rostock
Matthias Wittstock, MD study chair
Neurology, University Medical Center Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strokectomy/Necrosectomy in people with Stroke, Ischemic, run by University of Rostock at 1 site in Germany.
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 5 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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melanie Sparre (0381 494 6419, melanie.sparre@med.uni-rostock.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of resurgery after necrosectomy of malignant MCA-infarction (time frame: up to 2 weeks). 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 8 Jul 2024.