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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00398671
Other study ID # PreCoCa-1
Secondary ID
Status Completed
Phase Phase 2
First received November 13, 2006
Last updated February 26, 2015
Start date January 2006

Study information

Verified date December 2008
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients with primary successful CPR

Exclusion Criteria:

- Age < 18

- Pregnancy

- Severe bleeding or severe trauma

- Body core temperature < 34 degrees celsius

Study Design

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


Related Conditions & MeSH terms


Intervention

Device:
Application of cool cap after primary successful CPR


Locations

Country Name City State
Germany Charite University Hospital Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body core temperature at hospital/ ICU admission 1 day
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