Delayed Cold-Stored Platelets -PLTS-1
PLTS-1 is a multicentre, randomized, controlled, pilot trial, using a conventional, parallel group, two-armed design at 2 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT to determine the non-inferiority of cold-stored platelets compared to conventional plat
| Condition(s) | Platelets, Bleeding, Cardiopulmonary Bypass, Cardiac Surgery |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | PLTS-1 is a multicentre, randomized, controlled, pilot trial, using a conventional, parallel group, two-armed design at 2 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT to determine the non-inferiority of cold-stored platelets compared to conventional platelets with respect to hemostatic effectiveness (total number of allogeneic blood products transfused within 24 hours after CPB), as well as safety. |
| Who can participate | 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 surger |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Health Network, Toronto |
| Locations | Kingston, Ontario, Canada; Toronto, Ontario, Canada |
| Start date | 2024-06-05 |
| NCT ID | NCT06147531 |
| Official listing | https://clinicaltrials.gov/study/NCT06147531 |