Survival After Blood Transfusion in the French Administra... | NCT02852993

Studies
Survival After Blood Transfusion in the French Administrative Regions of Burgundy and Franche-Comté

NCT02852993

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Aug 2, 2016Estimated

Enrollment

16,099Actual

Phase

Not provided

Conditions

Erythrocyte Transfusion for All Conditions

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jul 29, 2016

First Submission Date that Met QC Criteria

Aug 1, 2016

First Posted Date

Aug 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2016

Last Update Posted Date

Aug 2, 2016Estimated

Name	Class
Centre Hospitalier Universitaire Dijon	OTHER
Etablissement Français du Sang	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16,099Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transfused patients		A cohort of patients receiving erythrocyte transfusion for the first time at the CHU Besançon or CHU Dijon during the study period.

Interventions

Not provided

Measure	Description	Time Frame
Survival		12 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maxime Desmarets, MD, PhD	Centre d'Investigation Clinique; CHU Besançon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre d'Investigation Clinique, CHU de Besançon		Besançon		25030	France
Département d'information Médicale, CHU Dijon

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26935140	Result	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.