Reperfusion With Cooling in Cerebral Acute Ischemia "ReCCLAIM"

Completed

Phase 1 Results

Trial Description

The purpose of this study is to determine whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).

Conditions

Interventions

  • Zoll- Coolgaurd 3000 Device
    Intervention Desc: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.
    ARM 1: Kind: Experimental
    Label: Mild Hypothermia
    Description: Reduction of body temperature to 34 degrees centigrade.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Reperfusion Injury \ Hemorrhagic transformation 24 Hours Yes
Secondary National Institute of Health Stroke Scale participants will be followed for the duration of hospital stay, an expected average of 7 dayss No
Secondary Modified Rankin Scale 90 days post hospitalization No
Primary Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation 24 Hours Yes
Secondary Modified Rankin Scale 0-2 90 days post hospitalization No

Sponsors