Allogenic Transfusion of Platelets During Cardiac SurgeryNCT01819246
High Yield Intraoperative, Autologous Platelet Apheresis
A study testing Aphersis Treatment Arm in people with Allogenic Transfusion of Platelets During Cardiac Surgery, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogenic Transfusion of Platelets During Cardiac Surgery
- What is being tested?
- Aphersis Treatment Arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: High Yield Intraoperative, Autologous Platelet Apheresis-Optomizing Transfusion Practice In Cardiac Surgery
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.
- Being tested
- Aphersis Treatment Arm, Control Arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aphersis Treatment ArmProcedure or surgery
Control ArmOther
| Study group | Role | What they receive |
|---|---|---|
| Pheresis Treatment Arm | Active comparator | Not described Receives: Procedure: Aphersis Treatment Arm |
| Control Arm | Sham comparator | Not described Receives: Other: Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of allogeneic platelet units transfused.
Measured: During the operative procedure
Secondary outcomes (1)
Overall blood product transfusion.
Measured: During the operative procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Allogenic Transfusion of Platelets During Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo BCT
- Responsible party
- Sponsor
- Investigators
- Ian Welsby, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819246
- Sponsor's protocol ID
- Pro00011798
- Status last verified
- Mar 2015
- First submitted
- 19 Feb 2013
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1161/01.str.0000053844.09493.58.
PubMed 12574568Ford 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.
PubMed 12073204
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Yield Intraoperative, Autologous Platelet Apheresis-Optomizing Transfusion Practice In Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01819246
- Acronym / sponsor ID
- Pro00011798
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Terumo BCT
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pheresis Treatment Arm | Active comparator | Procedure: Aphersis Treatment Arm |
| Control Arm | Sham comparator | Other: Control Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aphersis Treatment Arm | Procedure or surgery | Pheresis Treatment Arm |
| Control Arm | Other | Control Arm |
Primary outcome
Number of allogeneic platelet units transfused.
Time frame: During the operative procedure
1 secondary outcome
Overall blood product transfusion.
Time frame: During the operative procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Background: PubMed 12574568Mathew 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.
- Background: PubMed 12073204Ford 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Welsby, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aphersis Treatment Arm in people with Allogenic Transfusion of Platelets During Cardiac Surgery, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of allogeneic platelet units transfused. (time frame: During the operative procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01819246, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.