REperfusion With Cooling in CerebraL Acute IscheMia II "RECCLAIM-II"

Withdrawn

Phase 2 Results N/A

Trial Description

The purpose of this study is to determine whether reducing a patient's body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients who 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).This will be achieved by comparing patients who have undergone hypothermia to those who have not.

Detailed Description

This study is designed to examine the safety and proof of concept of therapeutic hypothermia prior to conventional revascularization in subjects experiencing acute ischemic stroke by comparing the results to subjects who remain at normal body temperature (normothermic) and proceed directly to reperfusion via conventional reperfusion intervention.
The investigational plan also examines the following outcomes in 85 subjects randomized to either hypothermia or normothermia:
- Regulation of biomarkers indicative of ischemia-reperfusion injury
- Changes in blood brain injury using the Hyperintense Acute Reperfusion Marker (HARM) protocol MRI as a surrogate imaging biomarker
- Incidence of hemorrhagic conversion post reperfusion
- Neurologic function at 90 days post acute ischemic stroke.
The results of this study will be used to power a definitive phase III clinical trial evaluating the combination of hypothermia and revascularization versus reperfusion alone.

Trial Stopped: It was decided that it was not feasible to continue this study.

Conditions

Interventions

  • Mild Hypothermia Procedure
    Other Names: Therapeutic hypothermia, clot retrieval, reperfusion
    Intervention Desc: Device: Zoll Thermogard XP technology with the Quattro catheter Device: Trevo Pro Retriever (Stryker Corp.)
    ARM 1: Kind: Experimental
    Label: Mild hypothermia
    Description: As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using current FDA cleared devices. Subjects will also have a catheter placed in the femoral vein and temperature brought to 33 degrees centigrade as quickly as possible. They will stay in mild hypothermia for 12 hours, and then be rewarmed very slowly.
  • Normothermia Procedure
    Other Names: Clot retrieval, reperfusion
    Intervention Desc: Device: Trevo Pro Retriever (Stryker Corp.)
    ARM 1: Kind: Experimental
    Label: Normothermia
    Description: As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using current FDA approved devices, after which normothermia will attempt to keep core body temp between 38 and 36.5 degrees centigrade.
  • Trevo Pro Retriever (Stryker Corp.) Device
    Intervention Desc: Device: Trevo Pro Retriever (Stryker Corp.)
    ARM 1: Kind: Experimental
    Label: Normothermia
    Description: As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using current FDA approved devices, after which normothermia will attempt to keep core body temp between 38 and 36.5 degrees centigrade.
    ARM 2: Kind: Experimental
    Label: Mild hypothermia
    Description: As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using current FDA cleared devices. Subjects will also have a catheter placed in the femoral vein and temperature brought to 33 degrees centigrade as quickly as possible. They will stay in mild hypothermia for 12 hours, and then be rewarmed very slowly.
  • Zoll Thermogard XP technology with the Quattro catheter Device
    Intervention Desc: Device: Zoll Thermogard XP technology with the Quattro catheter
    ARM 1: Kind: Experimental
    Label: Mild hypothermia
    Description: As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using current FDA cleared devices. Subjects will also have a catheter placed in the femoral vein and temperature brought to 33 degrees centigrade as quickly as possible. They will stay in mild hypothermia for 12 hours, and then be rewarmed very slowly.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Hemorrhagic Conversion 48 hours Yes
Secondary Hyperintense Acute Reperfusion Marker (HARM) 48 +/- 24 hours No
Secondary National Institutes of Health Stroke Scale (NIHSS) Baseline, 24 +/- 6 hours, 48 +/- 24 hours, 8 +/- 2 days, 90 +/- 15 days No
Secondary Modified Rankin Scale (mRS) Basline, 48 +/- 24 hours, 90 +/- 15 days No
Secondary Number of participants with adverse events 90 days Yes

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