Microparticles in Stored RBC as Potential Mediators of Transfusion Complications
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|ClinicalTrials.gov Identifier: NCT01185600|
Recruitment Status : Completed
First Posted : August 20, 2010
Results First Posted : November 23, 2016
Last Update Posted : July 2, 2017
INTRODUCTION. Cell-derived microparticles (MP) are released in cell activation, apoptosis and other processes. MP derived from red cells (RMP) are known to be released from stored packed red blood cells (PRBC), and their number increases with storage time. This constitutes one aspect of the storage lesion. Adverse transfusion events are known to increase with time of PRBC storage. The explanation for this is not known.
HYPOTHESIS. Based on their findings and those of others, the investigators propose to test the hypothesis that MP in stored PRBC contribute to adverse effects of transfusion. Specifically, MP in stored blood: (1) increase procoagulant activity, expression of pro-inflammatory mediators, immune suppression, and endothelial disturbance; and (2) increase the risk of transfusion and post-operative complications in patients undergoing coronary artery bypass grafting (CABG).
AIMS & PROCEDURES. The aim of this study is to assess the clinical significance of MPs in PRBC-related transfusion complications utilizing washed PRBC. Packed red blood cells (PRBC) will be washed at the blood bank to obtain MP depleted PRBC (PRBC-MP). A total of 500 patients undergoing CABG will be initially randomized to 2 groups: one to receive PRBC-MP, and the other conventional PRBC (PRBC+MP). Using a panel of lab tests/biomarkers selected for high sensitivity the investigators will compare the 2 groups with respect to subclinical physiologic host responses including (i) endothelial disturbances, (ii) inflammatory, and (iii) procoagulant responses. In addition, clinically evident transfusion complications and short term (<=30 days) surgical complications will be assessed and compared. Patients who are randomized but end up not requiring transfusion at surgery will serve as controls. Laboratory and clinical results will also be evaluated to elucidate which tests are significantly associated with clinically adverse effects.
SIGNIFICANCE. This study will shed new light on the biochemical and clinical effects of transfusion of MP. The findings of this investigation could significantly improve transfusion practice and safety.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Bypass||Biological: Washed RBC Biological: Unwashed RBC||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||177 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Microparticles in Stored Red Blood Cells (RBC) as Potential Mediators of Transfusion Complications (II): Clinical Study|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||May 2015|
Active Comparator: Transfusion with washed RBC
Subject assigned to this arm will be transfused with washed RBC
Biological: Washed RBC
There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject.
Other Name: Washed packed cells
Active Comparator: Transfusion with unwashed RBC
Subjects assigned to this arm will be transfused with unwashed RBC
Biological: Unwashed RBC
There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject.
Other Name: Unwashed packed cells
- In Hospital Mortality [ Time Frame: Within 30 days after CABG surgery ]The number of participants who expired during hospital stay after CABG surgery
- One-year Mortality [ Time Frame: Within one year after CABG surgery ]Number participants who expired within one year after CABG surgery
- Occurrence of at Least One Serious Adverse Event (SAE) [ Time Frame: within 30 days after CABG surgery ]Comparison of the two groups with respect to occurrence or not of at least one SAE including sepsis, respiratory failure, multi-organ failure, anaphylactic shock, transfusion-related acute lung injury, MI, stroke, cardiac arrest.
- Difference in Levels of Circulating CD41+ Platelet-derived Microparticles 1 Hour Post-surgery [ Time Frame: interval between presurgery and 1 hour post-surgery ]Difference in levels of circulating CD41+ platelet microparticles between at pre-surgery and at 1hour post-surgery, i.e. level at 1hour post-surgery - level at pre-surgery
- Difference in Levels of Circulating Annexin V+ Microparticles 1 Hour Post- Surgery [ Time Frame: Interval between pre-surgery and 1 hour post-surgery ]Difference in levels of circulating Annexin V+ microparticles between at pre-surgery and 1 hour post-surgery, i.e. level of Annexin V+ microparticles at 1 hour post-surgery - level of Annexin V+ microparticles at pre-surgery
- Difference in Levels of Circulating CD62E+ Endothelial Microparticles 1 Hour Post-surgery [ Time Frame: Interval between pre-surgery and 1 hour post-surgery ]Difference in levels of circulating CD62E+ endothelial microparticles between 1 hour post-surgery and at pre-surgery, i.e. level at 1 hour post-surgery - level at pre-surgery
- Difference in Levels of Circulating CD235a+ Red Cell Microparticles 1 Hour Post-surgery [ Time Frame: Interval between pre-surgery and 1 hour post-surgery ]Difference in levels of circulating CD235a+ red cell microparticles between at 1 hour post-surgery and at pre-surgery, i.e. levels at 1 hour post-surgery - level at pre-surgery
- Each Participant's Number of Non-serious Adverse Events [ Time Frame: Within 30 days after CABG surgery ]All clinical non-serious adverse events reported in the clinical chart were recorded in the study's data files. This type of events, defined as Non-Serious Adverse Events or just Adverse Events (AEs) were categorized into 5 groups: (1) Cardiovascular / respiratory; (2) renal; (3) neurologic (CNS); (4) infections; and (5) other. For each participant, the outcome measure was defined as the number of AE's he or she experienced during his/her hospital stay.
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): NCT01185600
|United States, Florida|
|Jackson Memorial Hospital|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Wenche Jy, PhD||University of Miami|