Microparticles in Stored RBC as Potential Mediators of Transfusion Complications
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Purpose
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 Graft Surgery |
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 |
- cell-derived microparticles [ Time Frame: one hour before surgery ] [ Designated as safety issue: Yes ]
Cell-derived microparticles are a group of biomarkers used for evaluating the host biochemical physiological responses including (1) endothelial dysfunction, (2)procoagulant/prothrombotic activities, and (3) proinflammatory activities.
Blood samples will be collected one hour before surgery for the measurement of cell-derived microparticles. The outcome of the measurement will be compared between arm 1 (washed RBC) and arm 2 (unwashed RBC).
- Cell-derived microparticles [ Time Frame: one hour after surgery ] [ Designated as safety issue: Yes ]Blood samples will be collected one hour after surgery for the measurement of cell-derived microparticles. The outcome of the measurement will be compared between arm 1 (washed RBC) and arm 2 (unwashed RBC).
- cell-derived microparticles [ Time Frame: one day after surgery ] [ Designated as safety issue: Yes ]Blood samples will be collected one day after surgery for the measurement of cell-derived microparticles. The outcome of the measurement will be compared between arm 1 (washed RBC) and arm 2 (unwashed RBC).
- cell-derived microparticles [ Time Frame: 7 days after surgery ] [ Designated as safety issue: Yes ]Blood samples will be collected 7 days after surgery for the measurement of cell-derived microparticles. The outcome of the measurement will be compared between arm 1 (washed RBC) and arm 2 (unwashed RBC).
- Transfusion-related adverse events [ Time Frame: within one year after surgery ] [ Designated as safety issue: Yes ]The major transfusion-related events include (1) allergic reactions, (2) hemolysis, (3) anaphylactic shock, (4)sepsis, (5) transfusion related acute lung injury,(6)death, and (7)miscellaneous: coronary artery diseases, thrombosis, bleeding, CNS dysfunction, stroke, renal failure, bleeding.
| Estimated Enrollment: | 500 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (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 Eligibility| Ages Eligible for Study: | 18 Years and older |
| 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| Contact: John Morgan, MD | 305-243-5308 | jmorgan1@med.miami.edu |
| Contact: Orlando Gomez-Marin, PhD | 305-243-6863 | ogomez@med.miami.edu |
| United States, Florida | |
| Jackson Memorial Hospital | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Eve Sakran, MS 305-585-7226 ext 1 esakran@jhsmiami.org | |
| Principal Investigator: Wenche Jy, PhD | |
| Sub-Investigator: Marco Ricci, MD | |
| Sub-Investigator: Sherry Shariatmadar, MD | |
| Sub-Investigator: Yeon S Ahn, MD | |
| Sub-Investigator: Orlando Gomez-Marin, PhD | |
| Principal Investigator: | Wenche Jy, PhD | University of Miami |
More Information
Publications:
| Responsible Party: | Wenche Jy, University of Miami |
| ClinicalTrials.gov Identifier: | NCT01185600 History of Changes |
| Other Study ID Numbers: | 20090685, R01HL098031 |
| Study First Received: | August 17, 2010 |
| Last Updated: | August 19, 2010 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by University of Miami:
|
transfusion complications washed RBC microparticles storage lesion |
ClinicalTrials.gov processed this record on May 19, 2013