Krieger 2001.
Methods | Eligible patients screened during the study period who were not enrolled served as concurrent controls Blinding: none Losses to follow up: none Intention to treat: unknown | |
Participants | Patients with a clinical diagnosis of acute ischaemic middle cerebral artery territory stroke Eligible for intravenous thrombolysis or intra‐arterial thrombolysis/thrombectomy and the initiation of moderate hypothermia within 5 hours of symptom onset (for patients treated with intravenous thrombolysis) or 8 hours after symptom onset (for patients treated with intra‐arterial thrombolysis) Mean age (SD) cooling blanket 71.1 years (14.3 years), control 68.2 years (12.3 years) 19 participants 10 male (53%) Stroke severity: (NIHSS) mean (SD) cooling blanket 19.8 (3.3), control 19.6 (2.6) Body temperature was measured in the bladder | |
Interventions | Cooling blanket (Aquamatic K‐Thermia EC600); ice water and whole body alcohol rubs were applied concurrently Control: none Duration: 12 to 72 hours | |
Outcomes | Body temperature Death or dependency (mRS ≥ 3) at 3 months Death at 3 months Intracranial/extracranial haemorrhage/haemorrhagic transformation of infarction Infections Other side effects: cardiac arrhythmias and hypotension | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | High risk | C ‐ Inadequate |
SD: standard deviation SSS: Scandinavian Stroke Scale mRS: modified Rankin Scale NIHSS: National Institutes of Health Stroke Scale