NCT00398671

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
Last Updated

February 27, 2015

Status Verified

December 1, 2008

Enrollment Period

5 months

First QC Date

November 13, 2006

Last Update Submit

February 26, 2015

Conditions

Heart Arrest

Keywords

primary successful cardio-pulmonary resuscitationpre-hospital setting

Outcome Measures

Primary Outcomes (1)

  • Body core temperature at hospital/ ICU admission

    1 day

Interventions

Application of cool cap after primary successful CPRDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with primary successful CPR

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University Hospital

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (1)

  • 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.

    PMID: 18512093DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Dietrich Hasper, MD

    Charite University Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 14, 2006

Study Start

January 1, 2006

Primary Completion

June 1, 2006

Last Updated

February 27, 2015

Record last verified: 2008-12

Locations

DE(1)