NCT01585597

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2 years until next milestone

Results Posted

Study results publicly available

August 1, 2014

Completed
Last Updated

August 1, 2014

Status Verified

July 1, 2014

Enrollment Period

3 months

First QC Date

April 22, 2012

Results QC Date

January 7, 2014

Last Update Submit

July 7, 2014

Conditions

Stroke, Acute

Keywords

Ischemic StokeEndovascular ReperfusionReperfusion InjuryMild hypothermia

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation

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

    24 Hours

Secondary Outcomes (1)

  • Modified Rankin Scale 0-2

    90 days post hospitalization

Study Arms (1)

Mild Hypothermia

EXPERIMENTAL

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

Device: Zoll- Coolgaurd 3000

Interventions

Zoll- Coolgaurd 3000DEVICE

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

Mild Hypothermia

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marcus Stroke and Neuroscience Center at Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Related Publications (1)

  • 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.

    PMID: 23468538DERIVED

MeSH Terms

Conditions

StrokeReperfusion Injury

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Christopher Horn
Organization
Emory University
cmhorn@emory.edu
404 387 7320

Study Officials

  • Rishi Gupta, MD

    Emory University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology and Neurosurgery

Study Record Dates

First Submitted

April 22, 2012

First Posted

April 26, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 1, 2014

Results First Posted

August 1, 2014

Record last verified: 2014-07

Locations

US(1)