Impact of Microparticles in Blood on Transfused Patient Outcomes (IMIB)
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|ClinicalTrials.gov Identifier: NCT03041974|
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : February 3, 2017
|Condition or disease||Intervention/treatment|
|Critical Care||Procedure: Red Blood Cell transfusion Procedure: Microparticles quantification|
During conservation of red blood cell concentrates, red blood cells (RBCs) undergo biochemical and morphological changes that have been well described, and are collectively termed " storage lesions ". The exact effects of these lesions in terms of beneficial or deleterious implications in the recipient remain to be elucidated. However, several retrospective studies in targeted populations suggest that an increase in the duration of RBC conservation could lead to an increase in morbidity and mortality in transfused patients. The multicenter, prospective trial ABLE (Age of Blood Evaluation, ISRCTN44878718) aimed to evaluate in a randomised clinical trial, the impact of the age of transfused RBC concentrates on several outcomes in critical care patients.
Among the modifications that RBCs undergo during storage, the generation of microparticles from red blood cellsRBCs or residual platelets present in the blood concentrate has never been evaluated in a prospective clinical study. It has been reported that the number of red cell-derived microparticles (RMPs) present in stored blood increases with storage duration. In vivo, microparticles MPs appear to be increasingly involved in disease processes, notably due to their pro-inflammatory and pro-coagulant effects. Furthermore, it has been shown that the antigens of the Rhesus group are expressed on the RBC derived microparticles, and the investigative team has shown that microparticles derived from elsewhere (endothelial cells) are capable of activating cells which are important in the induction of immune responses (dendritic cells). Thus, transfusing red blood cell derived microparticles could participate in post-transfusional alloimmunization which may also be evaluated in this study.
The aim of the IMIB study is to (1) quantify red cell- and platelet-derived microparticles MPs in RBC concentrates, and (2) evaluate the impact of the quantity of transfused microparticles (MPs) on survival and several outcomes in the patients enrolled in the ABLE trial in France.
Other aims are to investigate the relationship between the number of microparticles in RBC units and (1) the age of RBC, (2) donors characteristics, (3) the procedures used to prepare the blood products (to define a potential new "lesion storage" marker).
|Study Type :||Observational|
|Actual Enrollment :||280 participants|
|Official Title:||Cell-derived Microparticles in Red Blood Cell (RBC) Concentrates, and Their Potential Impact on Outcomes of Transfused Patients in Critical Care: a Prospective Multicentre National Cohort Study of Patients Included in the ABLE Trial|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||November 2014|
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
Flow cytometric quantification of microparticles in transfused blood
- All cause mortality [ Time Frame: 90 days ]
- All cause mortality [ Time Frame: 28 days, 6 months ]
- Multi organ dysfunction score [ Time Frame: 6 months ]
- Nosocomial infection [ Time Frame: 6 months ]including Nosocomial pneumonia, Deep tissue infections (e.g. peritonitis, mediastinitis), Bacteraemia from organisms not considered normal skin flora and judged important enough to treat by the attending team, as measured while in the ICU
- Intensive care and Hospital duration of stay [ Time Frame: 6 months ]
- Length of time requiring respiratory, haemodynamic and renal support [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041974
|Principal Investigator:||Francine Garnache-Ottou, PharmD, PhD||Etablissement Français du Sang, Besançon|