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Completed

NCT Number: NCT01819246

High Yield Intraoperative, Autologous Platelet Apheresis

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aphersis Treatment Arm

Procedure

Control Arm

Other

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Terumo BCT

Registry information

Official study title

High Yield Intraoperative, Autologous Platelet Apheresis-Optomizing Transfusion Practice In Cardiac Surgery

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2013
Registry last updated
Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.