Induced hypertension for delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a feasibility study

Recruiting

Conditions: intra-cerebral haemorrhage
brain haemorrhage
10007963

Registration Number: NL-OMON35291

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

1. Admission to the hospital
2. Age 18 years or over
3. Aneurysmal SAH, demonstrated on CT-angiography or cerebral agiograph, with onset less than 72 hours before admission
4. Glascow Coma Sum Score above 8.
5. DCI (decrease of 2 GSC points or all new neurological focal deficits), diagnosed by a neurologist, neurosurgeon or intensivist within 3 hours after deterioration.
6. Informed consent

Exclusion Criteria

1. Symptomatic cerebral aneurysm not yet treated by coiling or clipping
2. Co-existing severe head injury.
3. A history of a cardiac rhythm disorder, necessitating medical treatment.
4. A history of a left ventricular pump failure, necessitating medical treatment.
5. Pregnancy.
6. Known allergy for CT-contrast agents.
7. Renal failure, defined as a serum creatinine > 150 µmol/l
8. Other causes cause for neurological deterioration (see page 15 of the study protocol for the differential diagnosis)
9. Severe hypertension, defined as a MAP of 120 mmHg or higher

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. To test whether it is feasible to perform a multicentre randomised<br /><br>controlled trial on induced hypertension to<br /><br>improve neurological outcome after SAH.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Number of patients experiencing DCI as a proportion of the total amount of<br /><br>SAH patients.<br /><br>2. Reasons for exlusion<br /><br>3. Number of patients (in retrospective) with other causes of neurological<br /><br>deterioration.<br /><br>4. Difference in cerebral haemodynamics between the intervention groups.<br /><br>5. Neurological condition at the start and end of the study period.<br /><br>6. Neurological condition at 6 weeks after SAH.<br /><br>7. Number of complications and adverse events.</p><br>