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
; : 23969873241231047, 2024 Feb 12.
Article
en En
| MEDLINE
| ID: mdl-38347736
ABSTRACT
RATIONALE Decompressive craniectomy (DC) is beneficial in people with malignant middle cerebral artery infarction. Whether DC improves outcome in spontaneous intracerebral haemorrhage (ICH) is unknown. AIM:
To determine whether DC without haematoma evacuation plus best medical treatment (BMT) in people with ICH decreases the risk of death or dependence at 6 months compared to BMT alone. METHODS ANDDESIGN:
SWITCH is an international, multicentre, randomised (11), two-arm, open-label, assessor-blinded trial. Key inclusion criteria are age ⩽75 years, stroke due to basal ganglia or thalamic ICH that may extend into cerebral lobes, ventricles or subarachnoid space, Glasgow coma scale of 8-13, NIHSS score of 10-30 and ICH volume of 30-100 mL. Randomisation must be performed <66 h after onset and DC <6 h after randomisation. Both groups will receive BMT. Participants randomised to the treatment group will receive DC of at least 12 cm in diameter according to institutional standards. SAMPLE SIZE A sample of 300 participants randomised 11 to DC plus BMT versus BMT alone provides over 85% power at a two-sided alpha-level of 0.05 to detect a relative risk reduction of 33% using a chi-squared test.OUTCOMES:
The primary outcome is the composite of death or dependence, defined as modified Rankin scale score 5-6 at 6 months. Secondary outcomes include death, functional status, quality of life and complications at 180 days and 12 months.DISCUSSION:
SWITCH will inform physicians about the outcomes of DC plus BMT in people with spontaneous deep ICH, compared to BMT alone. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT02258919.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
6_ODS3_enfermedades_notrasmisibles
Problema de salud:
6_brain_nervous_system_cancer
/
6_cerebrovascular_disease
/
6_sense_organ_diseases
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Guideline
/
Prognostic_studies
Aspecto:
Patient_preference
Idioma:
En
Revista:
Eur Stroke J
Año:
2024
Tipo del documento:
Article
País de afiliación:
Suiza