COOL-Trial: Outcome With Invasive and Non-invasive Coolin... | NCT00843297

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

NCT00843297

Sponsor

University of Leipzig

Status

Completed

Last Update Posted

Feb 2, 2010Estimated

Enrollment

120Estimated

Phase

Phase 4

Conditions

Cardiac Arrest
Hypothermia

Interventions

Coolgard
ArcticSun
Conventional treatment

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Jan 2010Actual

First Submitted Date

Feb 12, 2009

First Submission Date that Met QC Criteria

Feb 12, 2009

First Posted Date

Feb 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2010

Last Update Posted Date

Feb 2, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CG	Active Comparator	Coolgard: invasive Cooling	Device: Coolgard
AS	Active Comparator	ArcticSun: Surface-Cooling	Device: ArcticSun
UnCOOL	Sham Comparator	No Cooling-Therapy due to non-operational cooling-devices	Other: Conventional treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coolgard	Device	invasive Cooling via femoral ICY-catheter	CG
ArcticSun

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to reach the target temperature		Twenty-four hours
NSE as a parameter for cerebral damage		Seventy-two hours

Secondary Outcomes

Measure	Description	Time Frame
Neurologic outcome		Six months
Survival		Six months
Periprocedural complications

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Holger Thiele, Associate Professor	Study Chair	Principal Investigator
Undine Pittl, MD	Study Sub-Investigator	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Leipzig, Heart Center, Cardiology		Leipzig		04289	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10625721	Background	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.
11856794

ID	Term
D006323	Heart Arrest
D007035	Hypothermia
D016757	Death, Sudden, Cardiac
D009461	Neurologic Manifestations

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001832	Body Temperature Changes
D012816	Signs and Symptoms