Impact of Microparticles in Blood on Transfused Patient Outcomes

NCT03041974 | Completed

• 1 other identifier: IMIB PHRC 2013
• Study Type: observational
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief Summary

During storage, red blood cells (RBCs) undergo changes collectively termed "Storage lesions". these changes may have an impact of the outcomes of transfused patients. One of these changes is the release of microparticles by RBCs and other blood cells types. The aim of the study is to (1) quantify red cell- and platelet-derived microparticles in RBC concentrates, and (2) evaluate the impact of transfused microparticles (MPs) on survival and post-transfusion complications in critical care patients participating in the ABLE trial (ISRCTN44878718).

Conditions

Critical Care

Keywords

Red Blood Cell Transfusion; Cell-Derived Microparticles

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  90 days

Secondary Outcomes (3)

• All cause mortality

  28 days, 6 months

• Multi organ dysfunction score

  6 months

• Nosocomial infection

  6 months

Other Outcomes (2)

• Intensive care and Hospital duration of stay

  6 months

• Length of time requiring respiratory, haemodynamic and renal support

  6 months

Study Arms (1)

Transfused critical care patients

Patients included in the Age of BLood Evaluation (ABLE) trial in either arms and included in a French center.

Procedure: Red Blood Cell transfusion; Procedure: Microparticles quantification

Interventions

Red Blood Cell transfusion PROCEDURE

Transfused critical care patients

Microparticles quantification PROCEDURE

Flow cytometric quantification of microparticles in transfused blood

Transfused critical care patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients included in the study are the patients enrolled, by french centers, in either arms of the ABLE trial.

You may qualify if:

• Have had a request for a first red cell unit transfusion in the Intensive Care Unit (ICU), and
• Have an anticipated length of invasive and/or non-invasive continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BIPAP) mechanical ventilation of at least 48 hours once enrolled, as estimated by the attending physician

You may not qualify if:

• less than 18 years of age
• previously enrolled in the ABLE study
• has already been transfused with red cells during the current hospitalisation
• has an obvious terminal illness documented in the medical record with a life expectancy of less than 3 months
• has undergone routine cardiac surgical care
• decision to withdraw/withhold some critical care had been made
• brain dead
• no red cells with a storage time of 7 days or less available in the blood bank that cannot be transported from the blood supplier
• Who require more than 1 unit of uncross-matched red cells
• With a known objection to blood transfusions
• With autologous blood donations
• Who pose difficulties in securing blood products (rare blood groups), and who are difficult to match

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Interventions

Erythrocyte Transfusion

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Francine Garnache-Ottou, PharmD, PhD

  Etablissement Français du Sang, Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: February 3, 2017
• Study Start: March 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share