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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 : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment Phase
Cerebral Hemorrhage Procedure: Decompressive craniectomy (DC) and best medical treatment Procedure: Best medical treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Swiss Trial of Decompressive Craniectomy Versus Best Medical Treatment of Spontaneous Supratentorial Intracerebral Hemorrhage (SWITCH): a Randomized Controlled Trial
Study Start Date : October 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Decompressive craniectomy and best medical treatment
Decompressive craniectomy and best medical treatment
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.


Active Comparator: Best medical treatment
Best medical treatment
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.




Primary Outcome Measures :
  1. Score in modified Rankin Scale (mRS) [ Time Frame: 6 months ]
    Assessed by telephone interview


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 7 days, 30 days, 180 days, 12 months ]
  2. mRS score of 0-3 versus 4-6 [ Time Frame: 30 days, 180 days, 12 months ]
  3. Categorical shift in mRS score [ Time Frame: 180 days, 12 months ]
  4. Quality of life [ Time Frame: 180 days, 12 months ]
  5. Death and intracranial hemorrhage [ Time Frame: intraoperative ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258919


Contacts
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Contact: Seraina Beyeler, PhD +41 632 39 70 seraina.beyeler@insel.ch
Contact: Patricia Plattner +41 632 60 66 patricia.plattner@insel.ch

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Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Study Director: Urs Fischer, Prof. Dr. med. Dep. of Neurology, Inselspital Bern
Study Chair: Jürgen Beck, Prof. Dr. med. Dep. of Neurosurgery, Inselspital Bern

Additional Information:
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02258919     History of Changes
Other Study ID Numbers: 163/14
32003B_150009 ( Other Grant/Funding Number: SNF )
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

Keywords provided by University Hospital Inselspital, Berne:
Intracerebral hemorrhage
Decompressive craniectomy
Randomized controlled trial
Acute stroke

Additional relevant MeSH terms:
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Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases