PreCoCa - "Prehospital Cooling With Cool-Caps" | NCT00398671

Studies
PreCoCa - "Prehospital Cooling With Cool-Caps"

NCT00398671

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Feb 27, 2015Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Heart Arrest

Interventions

Application of cool cap after primary successful CPR

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

Dec 2008

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

Jan 2006

Primary Completion Date

Jun 2006Actual

Completion Date

Not provided

First Submitted Date

Nov 13, 2006

First Submission Date that Met QC Criteria

Nov 13, 2006

First Posted Date

Nov 14, 2006Estimated

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 26, 2015

Last Update Posted Date

Feb 27, 2015Estimated

Description Module

Brief Summary

This study shall investigate the feasibility of the use of cool-caps in the preclinical setting in patients with successful primary cardio-pulmonary resuscitation Hypothesis: cool-caps are efficient and feasible to use in the preclinical setting in patients after successful CPR.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Application of cool cap after primary successful CPR	Device

Measure	Description	Time Frame
Body core temperature at hospital/ ICU admission		1 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with primary successful CPR

Exclusion Criteria:

Age < 18
Pregnancy
Severe bleeding or severe trauma
Body core temperature < 34 degrees celsius

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dietrich Hasper, MD	Charite University Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charite University Hospital		Berlin	State of Berlin	13353	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18512093	Derived	Storm C, Schefold JC, Kerner T, Schmidbauer W, Gloza J, Krueger A, Jorres A, Hasper D. Prehospital cooling with hypothermia caps (PreCoCa): a feasibility study. Clin Res Cardiol. 2008 Oct;97(10):768-72. doi: 10.1007/s00392-008-0678-1. Epub 2008 May 29.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases