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NCT01185600 · ClinicalTrials.gov registry record · NA
Microparticles in Stored RBC as Potential Mediators of Transfusion Complications
A NA study, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 177
- Enrollment target
NCT01185600 is a NA study that has completed, run by University of Miami. The registered enrollment target is 177 participants.
The verdict
NCT01185600, a NA study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 177 participants
- Enrollment target
Study 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 bioc
Interventions
- BIOLOGICAL Washed RBC
- BIOLOGICAL Unwashed RBC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2010-07 |
| Est. Completion | 2015-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01185600
The ClinicalTrials.gov registry entry for NCT01185600 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 177 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Washed RBC is the first listed.
NCT01185600 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01185600 about?
NCT01185600 is a clinical study titled "Microparticles in Stored RBC as Potential Mediators of Transfusion Complications". 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 ...
What is the current status of trial NCT01185600?
This trial is currently completed. It is a NA study. The enrollment target is 177 participants. The study started on 2010-07. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01185600?
The interventions under investigation include: Washed RBC (BIOLOGICAL), Unwashed RBC (BIOLOGICAL).
Who is sponsoring clinical trial NCT01185600?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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