Hemicraniectomy After Middle cerebral artery infarction with Life-threatening Edema Trial

Completed

• Conditions: Ischaemic stroke; space-occupying hemispheric infarction; Circulatory System; Stroke

• Registration Number: ISRCTN94237756
• Lead Sponsor: etherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-24
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Patients may be enrolled in the study if all of the following criteria are met:
1. Diagnosis of acute ischaemic stroke in the territory of the middle cerebral artery, with an onset within 96 hours prior to the planned start of the trial treatment
2. Score on the National Institutes of Health Stroke Scale (NIHSS) greater than or equal to 16 for right-sided lesions or greater than or equal to 21 for left-sided lesions
3. Gradual decrease in consciousness to a score of 13 or lower on the Glasgow Coma Scale (GCS) for right-sided lesions, or an eye and motor score of 9 or lower for left-sided lesions
4. Ischaemic changes on computed tomography (CT) involving two thirds or more of the territory of the middle cerebral artery (MCA), and space-occupying oedema formation. Displacement of midline structures on CT is not a requirement for inclusion.
5. Age 18 up to and including 60 years
6. Possibility to start trial treatment within 3 hours after randomisation
7. Written informed consent by a representative of the patient

Exclusion Criteria

Patients will be excluded from the study for any of the following reasons:
1. Ischaemic stroke of the entire cerebral hemisphere (anterior, middle, and posterior cerebral artery territories)
2. Decrease in consciousness (partially) explained by a cause other than oedema formation, such as metabolic disturbances or medication
3. Two fixed dilated pupils
4. Treatment with a thrombolytic agent in the 12 hours preceding randomisation
5. Known systemic bleeding disorder
6. Pre-stroke score on the modified Rankin Scale greater than 1 or less than 95 on the Barthel Index
7. Life expectancy less than 3 years
8. Other serious illness that may confound treatment assessment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score on the modified Rankin Scale (mRS) at one year

Secondary Outcome Measures

Name	Time	Method
The scores on the NIH Stroke Scale (NIHSS), the Barthel Index (BI), and the Montgomery and Asberg Depression Rating Scale (MADRS) and quality of life as measured with the SF36 and a visual analogue scale (VAS) at one year. In addition, the mRS, NIHSS, and BI will also be determined at 3 and 6 months, and the mRS, BI, MADRS, and SF36 also at 3 years after randomisation.