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Table 1 Criteria for eligibility and randomization

From: Slow recruitment in the HIMALAIA study: lessons for future clinical trials in patients with delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage based on feasibility data

Criteria for eligibility

Inclusion criteria

 Age above 18 years

 SAH with an aneurysmal bleeding pattern

Exclusion criteria

 Evidence of DCI after the SAH, unless symptoms of DCI started within 3 h

 Coexisting severe head injury

 Perimesencephalic hemorrhage

 A history of a ventricular cardiac rhythm disorder or heart failure necessitating medical treatment

 Likely transfer to another hospital, not participating in the trial, soon after treatment for the aneurysm

 Moribund

 Pregnancy

 No informed consent or informed consent not feasible

Additional exclusion criteria for the sub-study on cerebral perfusion

 Known allergy for CT contrast agents

 Renal failure, defined as a serum creatinine > 150 μmol/L

 Diabetes mellitus and glomerular filtration rate < 60

Criteria for randomisation

Inclusion criteria

DCI based on a decrease of at least 1 point on the Glasgow Coma Scale sum score and/or the development of new focal neurological deficits according to the NIHSS, diagnosed by a neurologist, neurosurgeon, intensivist, unless the deterioration does not reflect DCI as evaluated by the treating physician

Exclusion criteria

 Another cause for the neurological deterioration, e.g.

  Increasing hydrocephalus

  Recurrent bleeding

  Clinical signs of epilepsy

  Severe infectious disease with associated decrease in level of consciousness

  Hypoglycemia, defined as serum glucose < 3.0 mmol/L

  Hyponatremia, defined as serum sodium < 125 mmol/L

  Metabolic encephalopathy due to renal or hepatic failure

  Ischemia related to aneurysm treatment

 An untreated symptomatic aneurysm

 A spontaneous mean arterial pressure above 120 mmHg at the moment of randomization

 Any other contraindication for induced hypertension

 No CT-perfusion scan at time of neurological deterioration

 More than three contrast CT scans since admission

  1. CT Computerized tomography, NIHSS National Institutes of Health Stroke Scale, SAH Subarachnoid hemorrhage, DCI Delayed cerebral ischemia