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CompletedNCT00398671Updated Feb 27, 2015

PreCoCa - "Prehospital Cooling With Cool-Caps"

A Phase 2 interventional study of Application of cool cap after primary successful CPR in Heart Arrest, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-27.

Sponsored by Charite University, Berlin, Germany · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Arrest

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Keywords

  • primary successful cardio-pulmonary resuscitation
  • pre-hospital setting
03

In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 557 interventional studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients with primary successful CPR

Exclusion criteria

Exclusion Criteria:

  • Age \< 18
  • Pregnancy
  • Severe bleeding or severe trauma
  • Body core temperature \< 34 degrees celsius
05

Study design

Phase
Phase 2
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Interventions

  • DeviceApplication of cool cap after primary successful CPR
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What researchers measure

Primary outcomes

  1. Body core temperature at hospital/ ICU admission

    Time frame: 1 day

07

Study locations

1 site
  • Charite University Hospital
    Berlin, 13353, Germany
08

References and documents

Publications

  • Storm C, Schefold JC, Kerner T, Schmidbauer W, Gloza J, Krueger A, Jorres A, Hasper D. Prehospital cooling with hypothermia caps (PreCoCa): a feasibility study. Clin Res Cardiol. 2008 Oct;97(10):768-72. doi: 10.1007/s00392-008-0678-1. Epub 2008 May 29. PubMed 18512093 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00398671
Lead sponsor
Charite University, Berlin, Germany
First posted
Nov 14, 2006
Start date
Jan 2006
Primary completion
Jun 2006
Last update
Feb 27, 2015

Study contacts

Dietrich Hasper, MD
principal investigator · Charite University Medicine
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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