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PreCoCa - "Prehospital Cooling With Cool-Caps"

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.
ClinicalTrials.gov Identifier: NCT00398671
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : February 27, 2015
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Heart Arrest Device: Application of cool cap after primary successful CPR Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : January 2006
Primary Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

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 Posted: November 14, 2006    Key Record Dates
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