High Yield Intraoperative, Autologous Platelet Apheresis
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allogenic Transfusion of Platelets During Cardiac Surgery
Intervention: Aphersis Treatment Arm (Procedure); Control Arm (Other)
Phase: N/A
Status: Completed
Sponsored by: Duke University Official(s) and/or principal investigator(s): Ian Welsby, MD, Principal Investigator, Affiliation: Duke University
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.
Clinical Details
Official title: High Yield Intraoperative, Autologous Platelet Apheresis-Optomizing Transfusion Practice In Cardiac Surgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Number of allogeneic platelet units transfused.
Secondary outcome: Overall blood product transfusion.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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:
- 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.
Locations and Contacts
Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information
Related 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. 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.
Starting date: January 2013
Last updated: March 17, 2015
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