Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Microparticles in Stored RBC as Potential Mediators of Transfusion Complications

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Wenche Jy, University of Miami Identifier:
First received: August 17, 2010
Last updated: August 4, 2015
Last verified: August 2015

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 Intervention
Coronary Artery Bypass
Biological: Washed RBC
Biological: Unwashed RBC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Microparticles in Stored Red Blood Cells (RBC) as Potential Mediators of Transfusion Complications (II): Clinical Study

Resource links provided by NLM:

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • In hospital Mortality [ Time Frame: within 30 days after surgery ] [ Designated as safety issue: Yes ]
  • One-year Mortality [ Time Frame: within one year after surgery ] [ Designated as safety issue: Yes ]
  • Serious Adverse Events (sepsis, respiratory failure, multi-organ failure, anaphylactic shock, transfusion-related acute lung injury, MI, stroke, cardiac arrest) [ Time Frame: within 30 days after surgery ] [ Designated as safety issue: Yes ]
  • Non-serious adverse events [ Time Frame: within 30 days after surgery ] [ Designated as safety issue: Yes ]
  • cell-derived microparticles [ Time Frame: presurgery, day1, day3, and day7 post-surgery ] [ Designated as safety issue: No ]
    Cell-derived microparticles include red cell microparticles, platelet microparticles, leukocyte microparticles, endothelial microparticles

Enrollment: 197
Study Start Date: July 2010
Study Completion Date: May 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01185600

United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Wenche Jy, PhD University of Miami
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Wenche Jy, Research Associate Professor, University of Miami Identifier: NCT01185600     History of Changes
Other Study ID Numbers: 20090685  R01HL098031 
Study First Received: August 17, 2010
Last Updated: August 4, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Miami:
transfusion complications
washed RBC
storage lesion processed this record on October 27, 2016