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| Name | Class |
|---|---|
| Terumo BCT | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pheresis Treatment Arm | Active Comparator |
| |
| Control Arm | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aphersis Treatment Arm | Procedure |
| ||
| Control Arm |
| Measure | Description | Time Frame |
|---|---|---|
| Number of allogeneic platelet units transfused. | During the operative procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Overall blood product transfusion. | During the operative procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Welsby, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12574568 | Background | 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. | |
| 12073204 |
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| 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. |