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Decompressive Hemicraniectomy in Intracerebral Hemorrhage (SWITCH)

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ClinicalTrials.gov Identifier: NCT02258919
Recruitment Status : Recruiting
First Posted : October 8, 2014
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date  ICMJE September 30, 2014
First Posted Date  ICMJE October 8, 2014
Last Update Posted Date June 5, 2020
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2014)
Score in modified Rankin Scale (mRS) [ Time Frame: 6 months ]
Assessed by telephone interview
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2014)
  • Mortality [ Time Frame: 7 days, 30 days, 180 days, 12 months ]
  • mRS score of 0-3 versus 4-6 [ Time Frame: 30 days, 180 days, 12 months ]
  • Categorical shift in mRS score [ Time Frame: 180 days, 12 months ]
  • Quality of life [ Time Frame: 180 days, 12 months ]
  • Death and intracranial hemorrhage [ Time Frame: intraoperative ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Decompressive Hemicraniectomy in Intracerebral Hemorrhage
Official Title  ICMJE Swiss Trial of Decompressive Craniectomy Versus Best Medical Treatment of Spontaneous Supratentorial Intracerebral Hemorrhage (SWITCH): a Randomized Controlled Trial
Brief Summary

Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality rates up to 52% at 30 days. It is a major public health problem with an annual incidence of 10-30 per 100'000 population, accounting for 2 million (10-15%) of about 15 million strokes worldwide each year. The strategy of decompressive craniectomy (DC) is beneficial in patients with malignant middle cerebral artery (MCA) infarction. Based on the common pathophysiological mechanisms of these two conditions, this procedure is also frequently performed in patients with ICH, but is has not yet been investigated in a randomized trial.

The primary objective of this randomized controlled trial is to determine whether decompressive surgery and best medical treatment in patients with spontaneous ICH will improve outcome compared to best medical treatment only.

Secondary objectives are to analyze mortality, dependency and quality of life. Safety endpoints are to determine cause of any mortality and the rate of medical and surgical complications after DC compared with best medical treatment alone.

Detailed Description

Background

Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality rates up to 52% at 30 days. It is a major public health problem with an annual incidence of 10-30 per 100'000 population, accounting for 2 million (10-15%) of about 15 million strokes worldwide each year. One-third of patients with ICH die within one month and the majority of survivors remain handicapped. Neurological injury resulting from ICH is mediated by the mass effect of the hematoma, secondary to brain edema and/or both mechanisms. Treatment of ICH is one of the major unresolved issues of acute stroke treatment. The International Surgical Trials in Intracerebral Hemorrhage (STICH and STICH II) and other randomized controlled trials did not show any superiority of surgical treatment compared to conservative treatment approaches. Nevertheless, surgical treatment in ICH remains a matter of debate and attempts to improve outcome using surgical therapy are still ongoing. Many efforts are made to minimize the invasiveness of operative procedures such as clot evacuation. However, direct surgical interventions aiming at the removal of the hematoma have failed to improve neurological outcome for most subtypes of ICH, especially deep-seated hematomas. The trauma of open craniotomy and especially trauma to the brain parenchyma for hematoma evacuation are considered to outweigh the benefits of surgery.

Decompressive craniectomy (DC), which is beneficial in patients with malignant middle cerebral artery (MCA) infarction, may indirectly relieve the mass effect, decrease perihematomal tissue pressure, improve blood flow, reduce secondary brain damage and improve outcome without further damage to the brain due to surgery. Consequently, DC has been established as a standard surgical therapy for patients with malignant MCA infarction with a level of evidence grade 2. Decompressive craniectomy for acute stroke is one of the most effective treatments available: the number needed to be treated to save one patient's life is 2. Decompressive craniectomy is also a standard therapeutic procedure in patients with ICH due to sinus venous thrombosis, herpes encephalitis, or ruptured intracranial aneurysms. In patients with traumatic brain injury DC is a standard therapy to reduce elevated intracranial pressure. The investigators and others assessed whether DC is feasible and beneficial in patients with spontaneous intracranial hemorrhage. The investigators showed in a previous retrospective trial that DC in patients with supratentorial ICH is safe and feasible and may reduce mortality compared to matched controls with best medical treatment alone. The limitations of the feasibility trial are its retrospective design, the small sample size and the inhomogeneity of the patient cohort with respect to the origin of ICH. Furthermore, in the feasibility trial the decision for DC was taken on an individual basis rather than according to a strict protocol, introducing a potential selection bias. Nevertheless, the preliminary results are encouraging. Recently, three human trials, one animal study, one meta-analysis, and one original contribution have been published on this topic. However, no prospective randomized trial has ever assessed whether DC without hematoma evacuation in patients with acute ICH improves outcome. All recent studies showed promising results and all call for the initiation of a randomized controlled trial.

Objective

The primary objective of this randomized controlled trial is to determine whether decompressive surgery and best medical treatment in patients with spontaneous ICH will improve outcome compared to best medical treatment only.

Secondary objectives are to analyze mortality, dependency and quality of life. Safety endpoints are to determine cause of any mortality and the rate of medical and surgical complications after DC compared with best medical treatment alone.

Methods

All patients with a suspected intracerebral hemorrhage will be considered for this trial. Randomization of eligible patients will be performed within 66 hours after ictus in patients with stable clot volume and surgery no later than 6 hours after randomization. Patients randomized to the control group will receive best medical treatment according to international guidelines. Patients randomized to the treatment group will receive best medical treatment and a DC of at least 12cm according to institutional guidelines and a surgical protocol. The primary outcome death and dependency at 6 months will be assessed by a trained person unaware of treatment allocation. Favorable outcome is defined as a modified Rankin Scale (mRS) score of 0 to 4, poor outcome as modified Rankin Scale score of 5 or 6.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Hemorrhage
Intervention  ICMJE
  • Procedure: Decompressive craniectomy (DC) and best medical treatment

    Decompressive craniectomy:

    All patients in the treatment group will receive DC of at least 12 cm according to institutional guidelines and a published surgical protocol.

    Best medical treatment:

    Best medical treatment is based on American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation (ESO) as published in the current protocol from 2010 and 2014 respectively.

  • Procedure: Best medical treatment
    Best medical treatment is based on American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation (ESO) as published in the current protocol from 2010 and 2014 respectively.
Study Arms  ICMJE
  • Experimental: Decompressive craniectomy and best medical treatment
    Decompressive craniectomy and best medical treatment
    Intervention: Procedure: Decompressive craniectomy (DC) and best medical treatment
  • Active Comparator: Best medical treatment
    Best medical treatment
    Intervention: Procedure: Best medical treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2014)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent of the patient or of patient's next of kin plus consent of an independent physician if patient is unable to consent before randomization
  • Acute stroke syndrome due to a spontaneous ICH, defined as the sudden occurrence of bleeding into the parenchyma of the basal ganglia and/or thalamus that may extend into the ventricles and into the cerebral lobes, and into the subarachnoid space, confirmed by clinical history and imaging
  • Age: ≥18 to ≤75 years
  • Glasgow coma scale (GCS) <14 and >7
  • Neurological deficit with a NIHSS score of ≥10 and ≤30
  • Able to be randomly assigned to surgical treatment within 66 hours after ictus
  • Surgery performed not later than 6 hours after randomization
  • Volume of hematoma ≥30 ml and ≤100 ml
  • Stable clot volume
  • International normalized ratio (INR) <1.5, thrombocytes >100 T/ml

Exclusion Criteria

  • ICH due to known or suspected structural abnormality in the brain (e.g., intracranial aneurysm, brain arteriovenous malformation, brain tumor) or brain trauma, or previous stroke thrombolysis
  • Cerebellar or brainstem hemorrhage
  • Exclusive lobar hemorrhage
  • Known advanced dementia or significant pre-stroke disability
  • Concomitant medical illness that would interfere with outcome assessment and follow-up
  • Randomization not possible within 66 hours after ictus
  • Pregnancy
  • Prior major brain surgery within <6 month or prior DC
  • Foreseeable difficulties in follow-up due to geographic reasons
  • Known definite contraindication for a surgical procedure
  • A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
  • Previous participation in this trial or in another ongoing investigational trial
  • Prior symptomatic ICH
  • ICH secondary to thrombolysis
  • Bilateral areactive pupils
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seraina Beyeler, PhD +41 632 39 70 seraina.beyeler@insel.ch
Contact: Patricia Plattner +41 632 60 66 patricia.plattner@insel.ch
Listed Location Countries  ICMJE Austria,   Belgium,   Finland,   France,   Germany,   Netherlands,   Spain,   Sweden,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02258919
Other Study ID Numbers  ICMJE 163/14
32003B_150009 ( Other Grant/Funding Number: SNF )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Urs Fischer, Prof. Dr. med. Dep. of Neurology, Inselspital Bern
Study Chair: Jürgen Beck, Prof. Dr. med. Dep. of Neurosurgery, Inselspital Bern
PRS Account University Hospital Inselspital, Berne
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP