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Completed

NCT Number: NCT01585597

Reperfusion With Cooling in Cerebral Acute Ischemia

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).

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Marcus Stroke and Neuroscience Center at Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoll- Coolgaurd 3000

Device

Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.

Primary outcomes

  1. 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

Secondary outcomes

  1. Modified Rankin Scale 0-2

    Time frame: 90 days post hospitalization

    Modified Rankin Score 0=no symptoms

    • no significant disability
    • slight disability needs help
    • moderate disability
    • moderate serve disability
    • severe disability 0-2 = good outcome 3-5= poor outcome

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Acronym: ReCCLAIM

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 26, 2012
Registry last updated
Aug 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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