Arrest Cardio RespiratoryDESFERNCT03491670
Free Iron and Out of Hospital Cardiac Arrest
An observational study of Arrest Cardio Respiratory, run by University Hospital, Brest at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrest Cardio Respiratory
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2018to 16 Jul 2019
- Phase
- Observational
- 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
Study population: Patients admitted to ICU for out of hospital cardiac arrest
Who may be able to join
- Patient admitted to ICU for out of hospital cardiac arrest
- Therapeutic hypothermia
Who cannot join
- Absence of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Arrest Cardio Respiratory
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Neurologic outcome
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)
Measured: 6 months post cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start5 Jun 2018
- Primary completion5 Jun 2019
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrest Cardio RespiratoryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491670
- Sponsor's protocol ID
- DESFER (29BRC17.0154)
- Acronym
- DESFER
- Status last verified
- Nov 2019
- First submitted
- 26 Mar 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Metabolism After Out of Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03491670
- Acronym / sponsor ID
- DESFER / DESFER (29BRC17.0154)
- Conditions
- Arrest Cardio Respiratory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 9 Apr 2018 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to ICU for out of hospital cardiac arrest
Key inclusion criteria (2 listed)
- Patient admitted to ICU for out of hospital cardiac arrest
- Therapeutic hypothermia
Key exclusion criteria (1 listed)
- Absence of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: through study completion, an average of 1 year
Mortality
1 secondary outcome
Neurologic outcome
Time frame: 6 months post cardiac arrest
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 8 Oct 2020.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrest Cardio Respiratory, run by University Hospital, Brest at 1 site in France.
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 2 inclusion and 1 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 8 Oct 2020. 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 France. 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.
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?
Mortality (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2020.