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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02852993
Other study ID # P/2013/176
Secondary ID
Status Completed
Phase N/A
First received July 29, 2016
Last updated August 1, 2016
Start date September 2013
Est. completion date June 2015

Study information

Verified date July 2016
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority France: National Consultative Ethics Committee for Health and Life SciencesFrance: French Data Protection AuthorityFrance: Ethics Committee
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 16099
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms

  • Erythrocyte Transfusion for All Conditions

Locations

Country Name City State
France Centre d'Investigation Clinique, CHU de Besançon Besançon
France Département d'information Médicale, CHU Dijon Dijon

Sponsors (3)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon Centre Hospitalier Universitaire de Dijon, Etablissement Français du Sang

Country where clinical trial is conducted

France, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Survival 12 months Yes