Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Completed NA study, sponsored by University of Miami.

NCT01185600 is a NA study that has completed, run by University of Miami. The registered enrollment target is 177 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Primary Outcome

The number of participants who expired during hospital stay after CABG surgery

Interventions

  • BIOLOGICAL Washed RBC
  • BIOLOGICAL Unwashed RBC

Trial Details

FieldValue
Enrollment Target 177 participants
Start Date 2010-07
Est. Completion 2015-05
Phase NA
University of Miami

721 total trials

What the finished NCT01185600 record still lists

NCT01185600 is an interventional study that assigns participants to a tested intervention. The registered 177 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 2 interventions - of which Washed RBC is the first listed.

NCT01185600 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01185600's enrollment target sits among peer trials

177 604th of 2000 higher than 1,396 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT05491551 · 177 participants · NA

    Alcohol-ROC-Training

  • NCT06108050 · 177 participants · Phase 1

    JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors

  • NCT06575712 · 177 participants · NA

    Coping Skills Training for Symptom Management and Daily Steps (Step Up)

  • NCT06674980 · 177 participants · NA

    Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT01185600, the US trial registry maintained by the National Library of Medicine. NCT01185600 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.