High Yield Intraoperative, Autologous Platelet Apheresis

NCT01819246 | Completed DMC

• 1 other identifier: Pro00011798
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allogenic Transfusion of Platelets During Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Number of allogeneic platelet units transfused.

  During the operative procedure

Secondary Outcomes (1)

• Overall blood product transfusion.

  During the operative procedure

Study Arms (2)

Pheresis Treatment Arm

ACTIVE COMPARATOR

Procedure: Aphersis Treatment Arm

Control Arm

SHAM COMPARATOR

Other: Control Arm

Interventions

Aphersis Treatment Arm PROCEDURE

Pheresis Treatment Arm

Control Arm OTHER

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Terumo BCT: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• 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.

  PMID: 12574568 BACKGROUND

• 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.

  PMID: 12073204 BACKGROUND

Study Officials

• Ian Welsby, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: March 27, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 19, 2015

Record last verified: 2015-03

Locations

US (1)