Erythrocyte Transfusion for All ConditionsSTeF-BFCNCT02852993
Survival After Blood Transfusion in the French Administrative Regions of Burgundy and Franche-Comté
An observational study of Erythrocyte Transfusion for All Conditions, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
Trial summary
Red blood cell transfusion (RBC) is the main symptomatic treatment for severe anemia. RBC transfusion has proven its efficacy regarding mortality and morbidity, but it is not without side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythrocyte Transfusion for All Conditions
- How many people
- 16,099 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2013to Jun 2015
- 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: The eligible patients consisted of all adult patients transfused for the first time (defined as patients with no known history of RBC unit use in the transfusion register), at the university hospitals of Besançon or Dijon, between January 2007 and December 2011.
Who may be able to join
- Aged 18 and over
- Erythrocyte Transfusion between 2007 and 2011
- Performed at the University Hospital of Besançon or Dijon
Who cannot join
- Transfusion of any blood product prior to January 1st, 2007
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre d'Investigation Clinique, CHU de Besançon
Besançon, 25030
Département d'information Médicale, CHU Dijon
Dijon, 21079
About this study
Red blood cell transfusion (RBC) is the main symptomatic treatment for severe anemia. RBC transfusion has proven its efficacy regarding mortality and morbidity, but it is not without side effects. The infectious side effects of transfusion are largely considered under control, non-infectious side effects are taking center stage. Seeking explanations for the beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and optimal use of this precious resource.
The investigators aim to study the impact of donor and RBC characteristics on patient survival.
- Keywords
- Erythrocyte Transfusion, Survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transfused patients | A cohort of patients receiving erythrocyte transfusion for the first time at the CHU Besançon or CHU Dijon during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startSep 2013
- Primary completionJun 2015
- Study completionJun 2015
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 Erythrocyte Transfusion for All ConditionsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Retrospective
- Enrolment
- 16,099 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon, Etablissement Français du Sang
- Responsible party
- Sponsor
- Investigators
- Maxime Desmarets, MD, PhD, Principal investigator, Centre d'Investigation Clinique; CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852993
- Sponsor's protocol ID
- P/2013/176
- Acronym
- STeF-BFC
- Status last verified
- Jul 2016
- First submitted
- 29 Jul 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Desmarets M, Bardiaux L, Benzenine E, Dussaucy A, Binda D, Tiberghien P, Quantin C, Monnet E. Effect of storage time and donor sex of transfused red blood cells on 1-year survival in patients undergoing cardiac surgery: an observational study. Transfusion. 2016 May;56(5):1213-22. doi: 10.1111/trf.13537. Epub 2016 Mar 2.
PubMed 26935140
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival After Blood Transfusion in the French Administrative Regions of Burgundy and Franche-Comté
- ClinicalTrials.gov ID
- NCT02852993
- Acronym / sponsor ID
- STeF-BFC / P/2013/176
- Keywords
- Erythrocyte Transfusion, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,099 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon, Etablissement Français du Sang
- Study start
- Sep 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 Aug 2016 (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.
Red blood cell transfusion (RBC) is the main symptomatic treatment for severe anemia. RBC transfusion has proven its efficacy regarding mortality and morbidity, but it is not without side effects. The infectious side effects of transfusion are largely considered under control, non-infectious side effects are taking center stage. Seeking explanations for the beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and optimal use of this precious resource.
The investigators aim to study the impact of donor and RBC characteristics on patient survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transfused patients | – | –A cohort of patients receiving erythrocyte transfusion for the first time at the CHU Besançon or CHU Dijon during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The eligible patients consisted of all adult patients transfused for the first time (defined as patients with no known history of RBC unit use in the transfusion register), at the university hospitals of Besançon or Dijon, between January 2007 and December 2011.
Key inclusion criteria (3 listed)
- Aged 18 and over
- Erythrocyte Transfusion between 2007 and 2011
- Performed at the University Hospital of Besançon or Dijon
Key exclusion criteria (1 listed)
- Transfusion of any blood product prior to January 1st, 2007
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
Survival
Time frame: 12 months
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 2 Aug 2016.
- Results publication: PubMed 26935140Desmarets M, Bardiaux L, Benzenine E, Dussaucy A, Binda D, Tiberghien P, Quantin C, Monnet E. Effect of storage time and donor sex of transfused red blood cells on 1-year survival in patients undergoing cardiac surgery: an observational study. Transfusion. 2016 May;56(5):1213-22. doi: 10.1111/trf.13537. Epub 2016 Mar 2.
- Individual participant dataSharing planned: No
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.
Maxime Desmarets, MD, PhD principal investigator
Centre d'Investigation Clinique; CHU Besançon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erythrocyte Transfusion for All Conditions, run by Centre Hospitalier Universitaire de Besancon at 2 sites 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 3 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 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Survival (time frame: 12 months). 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 NCT02852993, 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 2 Aug 2016.