N/A
N=177
Microparticles in Stored RBC as Potential Mediators of Transfusion Complications
Coronary Artery Bypass
Bottom Line
View on ClinicalTrials.gov: NCT01185600 ↗Enrolled (actual)
177
Serious AEs
13.0%
Results posted
Nov 2016
Primary outcome: Primary: In Hospital Mortality — 0; 4 participants — p=0.142
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Washed RBC (Biological); Unwashed RBC (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In Hospital Mortality |
0; 4 | 0.142 |
| PRIMARY One-year Mortality |
0; 7 | 0.0391 sig |
| PRIMARY Occurrence of at Least One Serious Adverse Event (SAE) |
7; 6 | 0.372 |
| PRIMARY Difference in Levels of Circulating CD41+ Platelet-derived Microparticles 1 Hour Post-surgery |
-1059; 2034 | 0.1007 |
| PRIMARY Difference in Levels of Circulating Annexin V+ Microparticles 1 Hour Post- Surgery |
-3589; -680 | 0.0964 |
| PRIMARY Difference in Levels of Circulating CD62E+ Endothelial Microparticles 1 Hour Post-surgery |
36.4; 2.0 | 0.1739 |
| PRIMARY Difference in Levels of Circulating CD235a+ Red Cell Microparticles 1 Hour Post-surgery |
-344; -208 | 0.7205 |
| SECONDARY Each Participant's Number of Non-serious Adverse Events |
1.5; 2.4 | 0.0176 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients requiring coronary artery bypass (CABG) surgery will be enrolled into the study if they: (1) are willing and able to give informed consent and to adhere to study follow up requirements; and (2) do not satisfy any of the exclusion criteria
Exclusion Criteria
- Patients will be ineligible for the study if they (1) are unable or unwilling to give informed consent; (2) are unable or unwilling to follow the study protocol; (3) are less than 21 years of age; (4) require emergency procedures; (5) require cardiopulmonary bypass (pump) during the operation; (6) require other surgical procedures in addition to coronary artery bypass; (7) have a proven coagulation or platelet disorder; (8) are unwilling to receive blood transfusions; (9) are pregnant; or (10) have cognitive impairment.
Data sourced from ClinicalTrials.gov (NCT01185600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.