Heart ArrestPhase 2NCT00398671
PreCoCa - "Prehospital Cooling With Cool-Caps"
A Phase 2 study testing Application of cool cap after primary successful CPR in people with Heart Arrest, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest
- What is being tested?
- Application of cool cap after primary successful CPR
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Jun 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with primary successful CPR
Who cannot join
- Age < 18
- Pregnancy
- Severe bleeding or severe trauma
- Body core temperature < 34 degrees celsius
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Heart Arrest
- Being tested
- Application of cool cap after primary successful CPR
- Keywords
- primary successful cardio-pulmonary resuscitation, pre-hospital setting
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of cool cap after primary successful CPRDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Body core temperature at hospital/ ICU admission
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startJan 2006
- Primary completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Dietrich Hasper, MD, Principal investigator, Charite University Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398671
- Sponsor's protocol ID
- PreCoCa-1
- Status last verified
- Dec 2008
- First submitted
- 13 Nov 2006
- Last updated
- 27 Feb 2015
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PreCoCa - "Prehospital Cooling With Cool-Caps"
- ClinicalTrials.gov ID
- NCT00398671
- Acronym / sponsor ID
- PreCoCa-1
- Conditions
- Heart Arrest
- Keywords
- primary successful cardio-pulmonary resuscitation, pre-hospital setting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jun 2006 (actual)
- First posted
- 14 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with primary successful CPR
Key exclusion criteria (4 listed)
- Age < 18
- Pregnancy
- Severe bleeding or severe trauma
- Body core temperature < 34 degrees celsius
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of cool cap after primary successful CPR | Device | – |
Primary outcome
Body core temperature at hospital/ ICU admission
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Derived from this study: PubMed 18512093Storm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dietrich Hasper, MD principal investigator
Charite University Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Application of cool cap after primary successful CPR in people with Heart Arrest, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body core temperature at hospital/ ICU admission (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00398671, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2015; AzTrials last refreshed its copy on 31 Oct 2026.