TerminatedPhase 3

Induced Hypertension for Treatment of Delayed Cerebral Ischaemia After Aneurysmal Subarachnoid Haemorrhage

Stopped: As advised by the DSMB the study was stopped due to slow recruitment.

Netherlands26 participantsStarted 2010-08

Plain-language summary

The objective of this multi-centre, randomized controlled trial is to investigate the outcome after induced hypertension versus no induced hypertension in patients with delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (SAH), and to assess whether induced hypertension results in improved cerebral blood flow (CBF) as measured by means of perfusion-CT.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Admission to one of the participating study centres.
✓. Age 18 years or over.
✓. SAH with an aneurysmatic bleeding pattern.

Exclusion criteria

✕. Evidence of DCI after the SAH, defined as any decrease in the level of consciousness or the development of new focal neurological deficits after the onset of the SAH that is not due to increasing hydrocephalus, rebleeding of the aneurysm, epileptic seizure, septic- or metabolic encephalopathy, unless symptoms of DCI started within 3 hours.
✕. Co-existing severe head injury.
✕. Perimesencephalic haemorrhage (perimesencephalic bleeding pattern and no aneurysm on CT-angiography).
✕. A history of a ventricular cardiac rhythm disorder, necessitating medical treatment.
✕. A history of a left ventricular heart failure, necessitating medical treatment.
✕. Likely transfer to another hospital, not participating in the trial, soon after treatment for the aneurysm.

What they're measuring

The main outcome measurement will be the modified Rankin scale at 3 months after the SAH, compared between patients who were randomized to induced hypertension and patients who were randomized to no induced hypertension.

Timeframe: assessed three months after the SAH

Trial details

NCT IDNCT01613235

SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-01

View on ClinicalTrials.gov More Cerebral Ischemia trials