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CompletedNCT01819246Updated Mar 19, 2015

High Yield Intraoperative, Autologous Platelet Apheresis

An interventional study of Aphersis Treatment Arm and Control Arm in Allogenic Transfusion of Platelets During Cardiac Surgery, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-19.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The overall aim is to reduce overall allogeneic transfusion requirements during cardiac surgery when compared to standard management.

To evaluate this the investigators will test the hypothesis that intraoperative, autologous platelet apheresis will primarily avoid allogeneic platelet transfusion. Following induction of anesthesia and intravascular line insertion, the patient will be randomized to control or treatment arms by sealed envelope technique where computer generated, randomization numbers are assigned prior to enrollment based on study patient number which is never reused.

The control arm will have central venous access "sham" connected to the apheresis machine Trima® (Terumo BCT, Denver CO); the treatment arm will be connected and undergo pheresis. The clinical team will be blinded by a sterile sheet acting as a curtain and a recorded playback of the typical sounds of the operation of the apheresis machine. At the end of the pheresis, the platelet units will be disguised with opaque coverings and agitated at room temperature in compliance with the American Association of Blood Banks (AABB) recommendations for platelet storage. On separation from CPB, the blinded administration of autologous platelets or allogeneic (blood bank) platelets will occur after protamine administration, if the surgeon requests platelet transfusion (this is typically the case for these operations). The surgeon will be blinded and he will order subsequent transfusions based on clinical evidence of microvascular bleeding in accordance with standard guidelines, as is the investigators practice for these operations.

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Conditions studied

  • Allogenic Transfusion of Platelets During Cardiac Surgery
03

In context

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All elective, aortic reconstruction surgery and other patients at high risk of receiving platelet transfusions such as: combined CABG/valve, more than one valve surgery via median sternotomy, left ventricular assist devise, and pulmonary thromboarterectomy with deep hypothermic circulatory arrest cases.
  • Over 18 years of age

Exclusion criteria

Exclusion Criteria:

  • renal disease (dialysis dependent, end-stage renal disease or a baseline Cr >3mg/dl)
  • known coagulopathy/bleeding tendency (such as von Willebrand disease)
  • platelet count of \<150x109 /liter at baseline
  • Hct \< 30%
  • platelet inhibitory drugs within 5 days prior to surgery or Aspirin 325 mg within 48 hrs of surgery
  • inability to provide written, informed consent
  • patients receiving pre-operative parenteral, non-heparin anticoagulants will be excluded
  • pregnancy is not an exclusion criterion for the study but, typically, pregnancy is a contraindication to elective cardiac surgery hence pregnant patients are unlikely to be encountered.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
57 participants (actual)

Study arms

  • Active comparator
    Pheresis Treatment Arm

    Procedure: Aphersis Treatment Arm

  • Sham comparator
    Control Arm

    Other: Control Arm

Interventions

  • ProcedureAphersis Treatment Arm
  • OtherControl Arm
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What researchers measure

Primary outcomes

  1. Number of allogeneic platelet units transfused.

    Time frame: During the operative procedure

Secondary outcomes

  1. Overall blood product transfusion.

    Time frame: During the operative procedure

07

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
08

References and documents

Publications

  • Mathew JP, Grocott HP, Phillips-Bute B, Stafford-Smith M, Laskowitz DT, Rossignol D, Blumenthal JA, Newman MF; Neurologic Outcome Research Group of the Duke Heart Center; Cardiothoracic Anesthesiology Research Endeavors Investigators of the Duke Heart Center. Lower endotoxin immunity predicts increased cognitive dysfunction in elderly patients after cardiac surgery. Stroke. 2003 Feb;34(2):508-13. doi: 10.1161/01.str.0000053844.09493.58. PubMed 12574568 ↗
  • Ford SM, Unsworth-White MJ, Aziz T, Tooze JA, van Besouw JP, Bevan DH, Treasure T. Platelet pheresis is not a useful adjunct to blood-sparing strategies in cardiac surgery. J Cardiothorac Vasc Anesth. 2002 Jun;16(3):321-9. doi: 10.1053/jcan.2002.124141. PubMed 12073204 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01819246
Lead sponsor
Duke University
Collaborators
Terumo BCT
Responsible party
Sponsor
First posted
Mar 27, 2013
Start date
Jan 2013
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Mar 19, 2015

Study contacts

Ian Welsby, MD
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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