Prehospital COOLing 1 (PreCOOL 1) "PreCOOL"

Recruiting

Phase 2 Results N/A

Trial Description

Elevated body temperature was shown to be associated with worse outcome in acute stroke patients. PreCOOL 1 aims to investigate efficacy, feasibility and safety of prehospital cooling with cold infusions in stroke patients.

Conditions

Interventions

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Tympanic Temperature from randomization (prehospital) until arrival in the ER, an expected average of 45min No
Secondary Efficacy single measurement at arrival in the ER Yes
Secondary Vital parameters from randomization (prehospital) until arrival in the ER, an expected average of 45min Yes
Secondary Tolerability from randomization (prehospital) until arrival in the ER, an expected average of 45min Yes
Secondary Safety from randomization (prehospital) until first neuroimaging (ER), an expected average of 80min Yes

Sponsors