Survival After Blood Transfusion in the French Administrative Regions of Burgundy and Franche-Comté (STeF-BFC)

August 1, 2016 updated by: Centre Hospitalier Universitaire de Besançon

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

16099

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

  • France
      • Besançon, France, 25030
        • Centre d'Investigation Clinique, CHU de Besançon
      • Dijon, France, 21079
        • Département d'information Médicale, CHU Dijon

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

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.

Description

Inclusion Criteria:

  • Aged 18 and over
  • Erythrocyte Transfusion between 2007 and 2011
  • Performed at the University Hospital of Besançon or Dijon

Exclusion Criteria:

  • Transfusion of any blood product prior to January 1st, 2007

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besançon

Collaborators

Centre Hospitalier Universitaire Dijon
Etablissement Français du Sang

Investigators

  • Principal Investigator: Maxime Desmarets, MD, PhD, Centre d'Investigation Clinique; CHU Besançon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Estimate)

August 2, 2016

Last Update Submitted That Met QC Criteria

August 1, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P/2013/176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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