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PreCoCa - "Prehospital Cooling With Cool-Caps"

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00398671
First Posted: November 14, 2006
Last Update Posted: February 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charite University, Berlin, Germany
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 13, 2006
First Posted: November 14, 2006
Last Update Posted: February 27, 2015
Last Verified: December 2008

Keywords provided by Charite University, Berlin, Germany:
primary successful cardio-pulmonary resuscitation
pre-hospital setting

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases