Reperfusion With Cooling in Cerebral Acute Ischemia (ReCCLAIM)

July 7, 2014 updated by: Christopher M. Horn, MD, Emory University

Phase 1 Study of Mild Induced Hypothermia After Endovascular Revascularization in Acute Ischemic Stroke of the Anterior Circulation

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Marcus Stroke and Neuroscience Center at Grady Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-85 years old
  • Symptoms consistent with an ischemic stroke with a large vessel occlusion (MCA, ICA-terminus) as determined by vascular imaging
  • ASPECTS score of 5-7 on non-contrast CT of the brain
  • Ability to undergo endovascular reperfusion therapy
  • Must have no contraindications to general anesthesia
  • A pre-treatment modified Rankin Score of 0 or 1
  • Arterial puncture performed under 8 hours from symptom onset or last seen normal
  • Immediate post reperfusion CT scan shows no hemorrhage

Exclusion Criteria:

  • Bleeding diathesis with a platelet count < 50,000 or INR > 1.5
  • Involved in another clinical trial
  • History of dementia
  • End stage renal disease on hemodialysis
  • History of ventricular dysrhythmias
  • Life threatening medical condition precluding survival under 6 months
  • Presence of an IVC filter
  • Contrast dye allergy with history of anaphylaxis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mild Hypothermia
Reduction of body temperature to 34 degrees centigrade. This will be accomplished using the Zoll Coolguard .
Device: Zoll- Coolgaurd 3000
Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation
Time Frame: 24 Hours
Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying >30% of the infarct zone with mass effect
24 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale 0-2
Time Frame: 90 days post hospitalization

Modified Rankin Score 0=no symptoms

  1. no significant disability
  2. slight disability needs help
  3. moderate disability
  4. moderate serve disability
  5. severe disability 0-2 = good outcome 3-5= poor outcome
90 days post hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Study Director: Rishi Gupta, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

April 22, 2012

First Submitted That Met QC Criteria

April 24, 2012

First Posted (Estimate)

April 26, 2012

Study Record Updates

Last Update Posted (Estimate)

August 1, 2014

Last Update Submitted That Met QC Criteria

July 7, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00056889
  • MSNC 01 (Other Identifier: Other)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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