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


Phase 3 Results N/A

Eligibility Criteria

Inclusion criteria for eligibility
1. Admission to one of the participating study centres.
2. Age 18 years or over.
3. SAH with an aneurysmatic bleeding pattern.
Exclusion criteria for eligibility
1. 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.
2. Co-existing severe head injury.
3. Perimesencephalic haemorrhage (perimesencephalic bleeding pattern and no aneurysm on CT-angiography).
4. A history of a ventricular cardiac rhythm disorder, necessitating medical treatment.
5. A history of a left ventricular heart failure, necessitating medical treatment.
6. Likely transfer to another hospital, not participating in the trial, soon after treatment for the aneurysm.
7. Moribund.
8. Pregnancy.
And furthermore, in selected centres where the sub study with CT perfusion will be performed:
9. Known allergy for CT-contrast agents.
10. Renal failure, defined as a serum creatinine > 150 ┬Ámol/l, because of the risk of contrast nephropathy.
11. Diabetes mellitus.
Inclusion criteria for trial participation
1. Informed consent to participate in the proposed trial when DCI will develop.
2. DCI based on a decrease of at least one point on the Glasgow Coma Scale sum score unless the decrease doesn't reflect DCI as evaluated by the treating physician, and/or the development of new focal neurological deficits, diagnosed by a neurologist, neurosurgeon or intensivist.
Exclusion criteria for trial participation:
1. Another cause for neurological deterioration including.
2. A symptomatic aneurysm not yet treated by coiling or clipping.
3. Severe hypertension, defined as a spontaneous MAP of 120 mmHg or more at the moment of evaluation for trial participation.
4. 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:
5. No CTP scan at time of neurological deterioration.
6. More than 3 CTP scans since admission.