Cooling Plus Best Medical Treatment Versus Best Medical Treatment Alone for Acute Ischaemic Stroke "EuroHYP-1"

Recruiting

Phase 3 Results N/A

Trial Description

The purpose of this study is to determine if systemic cooling to a target temperature of 34 to 35°C, started within 6 hours of symptom onset and maintained for 24 hours, improves functional outcome at 3 months in patients with acute ischaemic stroke.

Conditions

Interventions

  • Hypothermia Device
    Intervention Desc: In patients randomised to therapeutic hypothermia, induction of cooling will be started by infusion of 4°C isotone saline or Ringer's lactate administered over a period of 30 to 60 minutes. A body temperature between 34.0 and 35.0°C will be targeted. Body temperature will be monitored through bladder or rectal thermal probes, and cooling procedures will be adapted to keep body temperature as close as possible to the target. Maintenance of body temperature in the target range will be performed with a surface or endovascular cooling device. After a cooling period of 24h, controlled rewarming to 36°C with a rate of 0.2°C/h will be started. After 36°C have been reached, the device will be disconnected.
    ARM 1: Kind: Experimental
    Label: Hypothermia
    Description: Best medical treatment + hypothermia 34-35°C for 24h
  • Buspirone Drug
    Intervention Desc: anti-shivering treatment
    ARM 1: Kind: Experimental
    Label: Hypothermia
    Description: Best medical treatment + hypothermia 34-35°C for 24h
  • Pethidine Drug
    Intervention Desc: anti-shivering treatment
    ARM 1: Kind: Experimental
    Label: Hypothermia
    Description: Best medical treatment + hypothermia 34-35°C for 24h

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary modified Rankin scale 3 months No
Secondary Mortality 3 months Yes
Secondary Neurological outcome 3 months No
Secondary Quality of life 3 months No
Secondary Cerebral infarct size 48±24 hours No
Secondary Safety of systemic cooling Enrollment - day 91 Yes
Secondary Tolerability of systemic cooling 36 hours No

Sponsors