Delayed Cold-Stored Platelets -PLTS-1

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Nov 23, 2023

Keywords

ClinConnect Summary

The PLTS-1 clinical trial is looking at a new way to store platelets, which are important for helping blood to clot, especially during cardiac surgery. Researchers want to find out if using cold-stored platelets is as effective and safe as the regular platelets typically used during surgery. This trial is taking place at two cardiac surgery centers in Canada and is currently recruiting adult patients who are 18 years and older and are scheduled for certain types of heart surgery. To be part of the study, patients need to have a higher risk of needing platelet transfusions, either due to their surgery or if they have a lower than normal platelet count.

Participants in this trial can expect to be randomly assigned to receive either the cold-stored platelets or the conventional platelets during their surgery. The main goal is to see how many blood products each group needs within 24 hours after surgery and to ensure that the cold-stored platelets are safe to use. It's important to note that some patients will not be eligible to participate, such as those with specific blood disorders, certain medications, or other health conditions that could complicate their surgery. This study is a step toward understanding if cold-stored platelets could be a helpful option for future patients undergoing heart surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult (≥18 years old) patients undergoing elective cardiac surgery with CPB will be eligible for inclusion if they are planned to undergo at least moderately complex surgery or have a preoperative platelet count ≤150,000 x106/L (this is a group at high risk of requiring platelet transfusions post-CPB).
• Moderately complex index surgery is defined as:
• • 1. repair/replacement of more than one valve;
• • 2. aorta (root/ascending/arch) replacement;
• • 3. any combination of coronary artery bypass grafting, valve repair/replacement, or aorta (root/ascending/arch) replacement; or
• • 4. re-do procedures consisting of a repair or revision of a prior cardiac intervention.
• Exclusion Criteria:
• Patients will be excluded if cold-stored platelets are not going to be available at the time of surgery or if the patient:
• • 1. has a congenital or acquired hemostatic disorder (including platelet refractoriness due to anti-platelet and anti-human leukocyte antigen \[HLA\] antibodies) and/or requires specially matched platelets (including patients with anaphylaxis to blood due to Immunoglobulin A \[IgA\] deficiency),
• • 2. has known contraindications to heparin, thereby excluding cases where non-reversible anticoagulants (i.e. argatroban) are used,
• • 3. is on warfarin or direct oral anticoagulants (dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to surgery,
• • 4. is on antiplatelet drugs within 5 days prior to surgery (excluding acetylsalicylic acid \[ASA\]),
• • 5. refuses allogeneic blood products,
• • 6. has a known pregnancy,
• • 7. has already enrolled in this study,
• • 8. is enrolled in another interventional clinical trial where routine care and management are altered,
• • 9. has hemodynamic instability defined as critical care admission, vasopressor, or inotrope dependence prior to index surgery, or
• • 10. has pre-operative requirement for, or expected post-operative dependence upon mechanical circulatory support (i.e., intra-aortic balloon pump, ventricular assist device).