- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03491670
Free Iron and Out of Hospital Cardiac Arrest (DESFER)
October 5, 2020 updated by: University Hospital, Brest
Iron Metabolism After Out of Hospital Cardiac Arrest
Out of hospital cardiac arrest is associated with a poor prognosis.
The aim of this study is to provide a better understanding of perturbations of iron metabolism after cardiac arrest and to analyze the impact on clinical centered outcome.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Brest, France, 29609
- CHRU de Brest
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to ICU for out of hospital cardiac arrest
Description
Inclusion Criteria:
- Patient admitted to ICU for out of hospital cardiac arrest
- Therapeutic hypothermia
Exclusion Criteria:
- Absence of consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: through study completion, an average of 1 year
|
Mortality
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurologic outcome
Time Frame: 6 months post cardiac arrest
|
Cerebral Performance Categories scale, ranging from 1 to 5, with a patient considered "1" when he has good cerebral performance and 5 when he has very poor cerebral performance (including brain death)
|
6 months post cardiac arrest
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 5, 2018
Primary Completion (ACTUAL)
June 5, 2019
Study Completion (ACTUAL)
July 16, 2019
Study Registration Dates
First Submitted
March 26, 2018
First Submitted That Met QC Criteria
April 6, 2018
First Posted (ACTUAL)
April 9, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 8, 2020
Last Update Submitted That Met QC Criteria
October 5, 2020
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DESFER (29BRC17.0154)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available after the publication of result and ending three years maximum following the last visit of the last patient
IPD Sharing Access Criteria
Data access requests will be reviewed by the international committee of Brest UH.
Requestors will be required to sign and completet a data access agreement
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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