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NCT01819246 · ClinicalTrials.gov registry record · NA
High Yield Intraoperative, Autologous Platelet Apheresis
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
NCT01819246 is a NA study that has completed, run by Duke University. The registered enrollment target is 57 participants.
The verdict
NCT01819246, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
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.
Interventions
- OTHER Control Arm
- PROCEDURE Aphersis Treatment Arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01819246
The ClinicalTrials.gov registry entry for NCT01819246 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Control Arm is the first listed.
NCT01819246 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01819246 about?
NCT01819246 is a clinical study titled "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. ...
What is the current status of trial NCT01819246?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2013-01. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01819246?
The interventions under investigation include: Control Arm (OTHER), Aphersis Treatment Arm (PROCEDURE).
Who is sponsoring clinical trial NCT01819246?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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