Decompressive Hemicraniectomy in Intracerebral Hemorrhage

NCT02258919 | Completed DMC

• 2 other identifiers: 163/1432003B_150009
• Study Type: interventional
• Target: 201
• Locations: 8 countries
• Sites: 32

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.

Conditions

Cerebral Hemorrhage

Keywords

Intracerebral hemorrhage; Decompressive craniectomy; Randomized controlled trial; Acute stroke

Outcome Measures

Primary Outcomes (1)

• Score in modified Rankin Scale (mRS)

  Assessed by telephone interview

  6 months

Secondary Outcomes (5)

• Mortality

  7 days, 30 days, 180 days, 12 months

• mRS score of 0-3 versus 4-6

  30 days, 180 days, 12 months

• Categorical shift in mRS score

  180 days, 12 months

• Quality of life

  180 days, 12 months

• Death and intracranial hemorrhage

  intraoperative

Study Arms (2)

Decompressive craniectomy and best medical treatment

EXPERIMENTAL

Decompressive craniectomy and best medical treatment

Procedure: Decompressive craniectomy (DC) and best medical treatment

Best medical treatment

ACTIVE COMPARATOR

Best medical treatment

Procedure: Best medical treatment

Interventions

Decompressive craniectomy (DC) and best medical treatment PROCEDURE

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.

Decompressive craniectomy and best medical treatment

Best medical treatment PROCEDURE

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.

Best medical treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (32)

Universitätsklinik für Neurochirurgie, Kepler Universitätsklinikum Linz

Linz, 4020, Austria

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Department of Neurology, Helsinki University Central Hospital

Helsinki, 00290, Finland

Location

Centre Hospitalier Universitaire de Caen

Caen, 14033, France

Location

Fondation Adolphe de Rothschild

Paris, 75019, France

Location

Klinik für Neurochirurgie, Universitätsklinikum Schleswig Holstein

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Klinik für Neurochirugie, Helios Klinikum Erfurt

Erfurt, Thuringia, 99089, Germany

Location

Klinik für Neurochirurgie Uniklinik RWTH Aachen

Aachen, 52074, Germany

Location

Department of Neurosurgery, Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Klinik und Poliklinik für Neurochirurgie, Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Klinik für Neurochirurgie, Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Neurologische Klinik, Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Klinik für Neurochirurgie, Universitätsklinikum Essen (AöR)

Essen, 45147, Germany

Location

Zentrum der Neurologie und Neurochirurgie, Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Klinik für Neurochirurgie, Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Neurochirurgische Klinik, Universitätsklinikum Gießen und Marburg UKGM

Giessen, 35392, Germany

Location

Klinik für Neurochirurgie, Universitätsmedizin Göttingen

Göttingen, 37075, Germany

Location

Klinik für Neurochirurgie, Klinikum Kassel

Kassel, 34125, Germany

Location

Neurochirurgische Klinik, Universitätsmedizin Mainz

Mainz, 55116, Germany

Location

Neurochirurgische Klinik, Universitätsklinikum Mannheim

Mannheim, 68167, Germany

Location

Dep. of Neurosurgery, Klinikum rechts der Isar der Technischen Universität München

Munich, 81675, Germany

Location

Klinik für Allgemeine Neurologie, Universitätsklinikum Münster

Münster, 48149, Germany

Location

Klinik für Neurochirurgie, Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Academic Medical Center Amsterdam, Department of Neurology

Amsterdam, 1105, Netherlands

Location

University Medical Center Utrecht, Department of Neurology, Department of Neurosurgery

Utrecht, 3584, Netherlands

Location

Servicio de Neurocirurgía Bellvitge Hospital

Barcelona, 08907, Spain

Location

Servicio de Neurología, Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Servicios de Neurología, Neurocirugía y Cuidados Intensivos del Hospital Virgen del Rocío

Seville, 41013, Spain

Location

Dep. of Neurology / Dep. of Neurosurgery, Bern University Hospital

Bern, 3010, Switzerland

Location

Dep. of Clinical Neuroscience, Service of Neurosurgery

Geneva, 1211, Switzerland

Location

Dep. Neurosurgery, Ospedale Regionale di Lugano

Lugano, 6903, Switzerland

Location

Dep. of Neurosurgery, University Hospital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (3)

• Polymeris AA, Lang MF, Hakim A, Butikofer L, Fung C, Beyeler S, Z'Graggen W, Strbian D, Vajkoczy P, Schubert GA, Gruber A, Mielke D, Roelz R, Siepen B, Seiffge DJ, Selim MH, Raabe A, Beck J, Fischer U; SWITCH Study Investigators. Effect of Decompressive Craniectomy According to Location of Deep Intracerebral Hemorrhage: A SWITCH Trial Analysis. Stroke. 2026 Jan;57(1):12-19. doi: 10.1161/STROKEAHA.125.052460. Epub 2025 Oct 17.

  PMID: 41104458 DERIVED

• Beck J, Fung C, Strbian D, Butikofer L, Z'Graggen WJ, Lang MF, Beyeler S, Gralla J, Ringel F, Schaller K, Plesnila N, Arnold M, Hacke W, Juni P, Mendelow AD, Stapf C, Al-Shahi Salman R, Bressan J, Lerch S, Hakim A, Martinez-Majander N, Piippo-Karjalainen A, Vajkoczy P, Wolf S, Schubert GA, Hollig A, Veldeman M, Roelz R, Gruber A, Rauch P, Mielke D, Rohde V, Kerz T, Uhl E, Thanasi E, Huttner HB, Kallmunzer B, Jaap Kappelle L, Deinsberger W, Roth C, Lemmens R, Leppert J, Sanmillan JL, Coutinho JM, Hackenberg KAM, Reimann G, Mazighi M, Bassetti CLA, Mattle HP, Raabe A, Fischer U; SWITCH study investigators. Decompressive craniectomy plus best medical treatment versus best medical treatment alone for spontaneous severe deep supratentorial intracerebral haemorrhage: a randomised controlled clinical trial. Lancet. 2024 Jun 1;403(10442):2395-2404. doi: 10.1016/S0140-6736(24)00702-5. Epub 2024 May 15.

  PMID: 38761811 DERIVED

• Fischer U, Fung C, Beyeler S, Butikofer L, Z'Graggen W, Ringel F, Gralla J, Schaller K, Plesnila N, Strbian D, Arnold M, Hacke W, Juni P, Mendelow AD, Stapf C, Al-Shahi Salman R, Bressan J, Lerch S, Bassetti CLA, Mattle HP, Raabe A, Beck J. Swiss trial of decompressive craniectomy versus best medical treatment of spontaneous supratentorial intracerebral haemorrhage (SWITCH): an international, multicentre, randomised-controlled, two-arm, assessor-blinded trial. Eur Stroke J. 2024 Sep;9(3):781-788. doi: 10.1177/23969873241231047. Epub 2024 Feb 12.

  PMID: 38347736 DERIVED

Related Links

• Website of the trial

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke

Interventions

Decompressive Craniectomy

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Decompression, Surgical; Surgical Procedures, Operative; Craniotomy; Neurosurgical Procedures

Study Officials

• Urs Fischer, Prof. Dr. med.

  Dep. of Neurology, Inselspital Bern

  STUDY DIRECTOR

• Jürgen Beck, Prof. Dr. med.

  Dep. of Neurosurgery, Inselspital Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 8, 2014
• Study Start: October 1, 2014
• Primary Completion: October 15, 2023
• Study Completion: May 23, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

FI (1); FR (2); NL (2); ES (3); DE (18); AU (1); BE (1); CH (4)