PreCoCa - "Prehospital Cooling With Cool-Caps"

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00398671
First received: November 13, 2006
Last updated: February 26, 2015
Last verified: December 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

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

Primary Outcome Measures:
  • Body core temperature at hospital/ ICU admission [ Time Frame: 1 day ]

Estimated Enrollment: 50
Study Start Date: January 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00398671     History of Changes
Other Study ID Numbers: PreCoCa-1
Study First Received: November 13, 2006
Last Updated: February 26, 2015
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

Additional relevant MeSH terms:
Heart Arrest
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on September 02, 2015