Reperfusion With Cooling in Cerebral Acute Ischemia

NCT ID: NCT01585597

Last Updated: 2014-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-08-31

Brief Summary

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

Stroke, Acute

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mild Hypothermia

Reduction of body temperature to 34 degrees centigrade. This will be accomplished using the Zoll Coolguard .

Group Type: EXPERIMENTAL

Zoll- Coolgaurd 3000

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Christopher M. Horn, MD

Assistant Professor of Neurology and Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rishi Gupta, MD

Role: STUDY_DIRECTOR

Emory University

Locations

Marcus Stroke and Neuroscience Center at Grady Memorial Hospital

Atlanta, Georgia, United States

Countries

United States

References

Horn CM, Sun CH, Nogueira RG, Patel VN, Krishnan A, Glenn BA, Belagaje SR, Thomas TT, Anderson AM, Frankel MR, Schindler KM, Gupta R. Endovascular Reperfusion and Cooling in Cerebral Acute Ischemia (ReCCLAIM I). J Neurointerv Surg. 2014 Mar;6(2):91-5. doi: 10.1136/neurintsurg-2013-010656. Epub 2013 Mar 6.

Reference Type: DERIVED

PMID: 23468538 (View on PubMed)

Other Identifiers

MSNC 01

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00056889

Identifier Type: -

Identifier Source: org_study_id