Induced hypertension for treatment of delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage.

Phase 3

Completed

• Conditions: brain haemorrhage; intracerebral haemorrhage; 10007963

• Registration Number: NL-OMON38214
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

1. Admission to the hospital 2. Age 18 years or over 3. Aneurysmal SAH, demonstrated on CT-angiography or cerebral angiograph 4. DCI (decrease of at least one point on the GSC sumscore, unless the decrease doesn*t reflect DCI as evaluated by the treating physician, and/or all new neurological focal deficits), diagnosed by a neurologist, neurosurgeon or intensivist, 5. Informed consent

Exclusion Criteria

0. Evidence of DCI after the SAH at time of asking for informed consent, unless symptoms of DCI started within 3 hours 1. Co-existing severe head injury. 2. A perimesencephalic haemorrhage. 3. A history of a ventricular cardiac rhythm disorder, necessitating medical treatment. 4. A history of left ventricular heart failure, necessitating medical treatment. 5. Pregnancy. 6. Transferral to another hospital, 7. moribund, 8. Other cause for neurological deterioration (see page 19 of the study protocol for the differential diagnosis) 9. Symptomatic cerebral aneurysm not yet treated by coiling or clipping, 10. Severe hypertension, defined as a spontaneous MAP of 120 mmHg or more at the moment of evaluation for trial participation, 11. Any contraindication for induced hypertension (such as a cardiac complication necessitating medical treatment) as evaluated by the treating physician. And furthermore, in selected centres where the sub study with CT perfusion will be performed: 12. known allergy for CT-contrast agents. 13. renal failure, defined as a serum creatinine > 150 µmol/l, because of the risk of contrast nephropathy. 14. diabetes mellitus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter will be the proportion of SAH patients with DCI<br /><br>with poor outcome three months after the SAH, defined as a modified Rankin<br /><br>Scale score of 3 or more. </p><br>