PreCoCa - "Prehospital Cooling With Cool-Caps"

This study is ongoing, but not recruiting participants.

First Received: November 13, 2006 Last Updated: December 4, 2008 History of Changes

Sponsored by:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00398671

Purpose

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.

Condition	Intervention	Phase
Heart Arrest	Device: Application of cool cap after primary successful CPR	Phase II

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: CPR

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398671

Locations

Germany
Charite University Hospital
Berlin, Germany, 13353

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator:

Dietrich Hasper, MD

Charite University Medicine

More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Storm C, Schefold JC, Kerner T, Schmidbauer W, Gloza J, Krueger A, Jörres A, Hasper D. Prehospital cooling with hypothermia caps (PreCoCa): a feasibility study. Clin Res Cardiol. 2008 Oct;97(10):768-72. Epub 2008 May 29.

Study ID Numbers:	PreCoCa-1
Study First Received:	November 13, 2006
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00398671 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:

primary successful cardio-pulmonary resuscitation
pre-hospital setting

Study placed in the following topic categories:

Heart Diseases
Heart Arrest

Additional relevant MeSH terms:

Heart Diseases
Cardiovascular Diseases
Heart Arrest

ClinicalTrials.gov processed this record on September 11, 2009