ReCCLAIM: Reperfusion With Cooling in Cerebral Acute Ischemia

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01585597
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute	Device: Zoll- Coolgaurd 3000	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1 Study of Mild Induced Hypothermia After Endovascular Revascularization in Acute Ischemic Stroke of the Anterior Circulation
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation [24 Hours]

   Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying >30% of the infarct zone with mass effect

Secondary Outcome Measures

1. Modified Rankin Scale 0-2 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marcus Stroke and Neuroscience Center at Grady Memorial Hospital	Atlanta	Georgia	United States	30303

Sponsors and Collaborators

• Emory University

Investigators

• Study Director: Rishi Gupta, MD, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christopher M. Horn, MD, Assistant Professor of Neurology and Neurosurgery, Emory University
• ClinicalTrials.gov Identifier: NCT01585597
• Other Study ID Numbers: IRB00056889; MSNC 01
• First Posted: Apr 26, 2012
• Last Update Posted: Aug 1, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Christopher M. Horn, MD, Assistant Professor of Neurology and Neurosurgery, Emory University: Ischemic Stoke; Endovascular Reperfusion; Reperfusion Injury; Mild hypothermia
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	Mild Hypothermia
Arm/Group Description	Reduction of body temperature to 34 degrees centigrade. 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.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Mild Hypothermia
Arm/Group Description	Reduction of body temperature to 34 degrees centigrade. 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.
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (14)
Sex: Female, Male (Count of Participants)
Female	8 40%
Male	12 60%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mild Hypothermia
Arm/Group Description	Reduction of body temperature to 34 degrees centigrade. 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.
Measure Participants	20
Number [participants]	3 15%

2. Secondary Outcome

Title	Modified Rankin Scale 0-2
Description	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
Time Frame	90 days post hospitalization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mild Hypothermia
Arm/Group Description	Reduction of body temperature to 34 degrees centigrade. 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.
Measure Participants	20
Number [participants Modified Rankin Scal 0-2]	20 100%

Adverse Events

Time Frame	90 days
Arm/Group Title	Mild Hypothermia
Arm/Group Description	Reduction of body temperature to 34 degrees centigrade. 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.
All Cause Mortality
	Mild Hypothermia
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Mild Hypothermia
	Affected / at Risk (%)	# Events
Total	8/20 (40%)
Blood and lymphatic system disorders
Deep Venous Thrombosis	1/20 (5%)	1
Infections and infestations
Pneumonia	5/20 (25%)	5
Bacteremia	1/20 (5%)	1
Urinary Tract Infection	4/20 (20%)	4
Other (Not Including Serious) Adverse Events
	Mild Hypothermia
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.