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COOL-Trial: Outcome With Invasive and Non-invasive Cooling After Cardiac Arrest (COOL)

Primary Purpose

Cardiac Arrest, Hypothermia

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Coolgard
ArcticSun
Conventional treatment
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Sudden Cardiac Arrest, Hypothermia, Outcome, neurological, Coolgard, ArcticSun

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ROSC after SCA due to VF/VT or PEA/Asystolia
  • GCS 3

Exclusion Criteria:

  • Non-cardiac SCA
  • Pregnancy
  • Unstable Circulation instead of High-dose Inotropics
  • Life-expectancy reducing concomitant illness

Sites / Locations

  • University of Leipzig, Heart Center, Cardiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

CG

AS

UnCOOL

Arm Description

Coolgard: invasive Cooling

ArcticSun: Surface-Cooling

No Cooling-Therapy due to non-operational cooling-devices

Outcomes

Primary Outcome Measures

Time to reach the target temperature
NSE as a parameter for cerebral damage

Secondary Outcome Measures

Neurologic outcome
Survival
Periprocedural complications

Full Information

First Posted
February 12, 2009
Last Updated
February 1, 2010
Sponsor
University of Leipzig
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1. Study Identification

Unique Protocol Identification Number
NCT00843297
Brief Title
COOL-Trial: Outcome With Invasive and Non-invasive Cooling After Cardiac Arrest
Acronym
COOL
Official Title
Clinical and Neurological Outcome With Two Different Cooling Methods (Invasive and Non-invasive) After Sudden Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Leipzig

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the efficacy and side effects of therapeutic hypothermia in an unselected group of patients after SCA.
Detailed Description
Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC). Blood samples of neuron-specific enolase (NSE) were collected during 72 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Hypothermia
Keywords
Sudden Cardiac Arrest, Hypothermia, Outcome, neurological, Coolgard, ArcticSun

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CG
Arm Type
Active Comparator
Arm Description
Coolgard: invasive Cooling
Arm Title
AS
Arm Type
Active Comparator
Arm Description
ArcticSun: Surface-Cooling
Arm Title
UnCOOL
Arm Type
Sham Comparator
Arm Description
No Cooling-Therapy due to non-operational cooling-devices
Intervention Type
Device
Intervention Name(s)
Coolgard
Intervention Description
invasive Cooling via femoral ICY-catheter
Intervention Type
Device
Intervention Name(s)
ArcticSun
Intervention Description
Noninvasive surface-cooling by saline-cooled thermo-vest
Intervention Type
Other
Intervention Name(s)
Conventional treatment
Intervention Description
Intensive care-treatment without cooling
Primary Outcome Measure Information:
Title
Time to reach the target temperature
Time Frame
Twenty-four hours
Title
NSE as a parameter for cerebral damage
Time Frame
Seventy-two hours
Secondary Outcome Measure Information:
Title
Neurologic outcome
Time Frame
Six months
Title
Survival
Time Frame
Six months
Title
Periprocedural complications
Time Frame
Seventy-two hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ROSC after SCA due to VF/VT or PEA/Asystolia GCS 3 Exclusion Criteria: Non-cardiac SCA Pregnancy Unstable Circulation instead of High-dose Inotropics Life-expectancy reducing concomitant illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Thiele, Associate Professor
Organizational Affiliation
Study Chair
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Undine Pittl, MD
Organizational Affiliation
Study Sub-Investigator
Official's Role
Study Director
Facility Information:
Facility Name
University of Leipzig, Heart Center, Cardiology
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
10625721
Citation
Zeiner A, Holzer M, Sterz F, Behringer W, Schorkhuber W, Mullner M, Frass M, Siostrzonek P, Ratheiser K, Kaff A, Laggner AN. Mild resuscitative hypothermia to improve neurological outcome after cardiac arrest. A clinical feasibility trial. Hypothermia After Cardiac Arrest (HACA) Study Group. Stroke. 2000 Jan;31(1):86-94. doi: 10.1161/01.str.31.1.86.
Results Reference
background
PubMed Identifier
11856794
Citation
Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.
Results Reference
background

Learn more about this trial

COOL-Trial: Outcome With Invasive and Non-invasive Cooling After Cardiac Arrest

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