Status:
TERMINATED
Induced Hypertension for Delayed Cerebral Ischaemia After Aneurysmal Subarachnoid Haemorrhage:a Feasibility Study
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Netherlands Organisation for Scientific Research
Conditions:
Cerebral Ischemia
Subarachnoid Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test the feasibility of a trial on induced hypertension to improve neurological outcome in patients with subarachnoid haemorrhage that developed the serious complicatio...
Detailed Description
Background: Delayed cerebral ischaemia (DCI) is a major complication after aneurysmal subarachnoid haemorrhage (SAH). The proportion of SAH patients who develop DCI is around 30%. Many centres around...
Eligibility Criteria
Inclusion
- Admission to the UMC Utrecht.
- Age 18 years or over.
- Aneurysmal SAH, demonstrated on CT-angiography or cerebral angiography, with onset less than 72 hours before admission.
- A level of consciousness corresponding to a Glasgow Coma Sum Score above 8, as in patients with lower Glasgow Coma Sum Scores, assessment of further deterioration may be less reliable.
Exclusion
- Symptomatic aneurysm not yet treated by coiling or clipping. Co-existing asymptomatic cerebral aneurysms are no reason for exclusion, since previous studies found no increased risk of rupture of such aneurysms during hypertensive and hypervolemic treatment.(26)
- Co-existing severe head injury.
- A history of a cardiac rhythm disorder, necessitating medical treatment.
- A history of a left ventricular pump failure, necessitating medical treatment.
- Pregnancy.
- Known allergy for CT-contrast agents.
- Renal failure, defined as a serum creatinine \> 150 µmol/l, because of the risk of contrast nephropathy.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00841633
Start Date
February 1 2009
End Date
April 1 2011
Last Update
October 12 2011
Active Locations (1)
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1
UMC Utrecht
Utrecht, Utrecht, Netherlands, 3508GA