Toronto General Hospital - University Health Network
Toronto, Ontario, M5G 2C4, Canada
Location contact
Justyna Bartoszko, MD MSc FRCPC
CONTACT
(416) 340-4800 ext. 3243
Justyna Bartoszko, MD MSc FRCPC
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07064954
The Auto-PLTS Study is a single-centre trial performed at Toronto General Hospital (TGH) that uses a randomized, patient preference design. The recent introduction of cold-stored platelets with a shelf-life of 14 days into clinical practice has made it possible to offer autologous apheresis platelet predonation to patients undergoing elective cardiac (and other high-blood-loss) surgeries while allowing sufficient time to recover platelet count before surgery. The Auto-PLTS Study is designed to assess whether replacing allogeneic platelets with autologous platelets will improve patient outcomes and benefit the healthcare system by reducing the burden on allogeneic platelet supply. The study is also designed to determine whether patients are willing to donate autologous platelets 7-10 days prior to surgery.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Toronto, Ontario, M5G 2C4, Canada
Justyna Bartoszko, MD MSc FRCPC
CONTACT
(416) 340-4800 ext. 3243
Justyna Bartoszko, MD MSc FRCPC
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adult (≥18 years old) patients who meet all following criteria:
Exclusion criteria
Patients who meet any of the following criteria are not eligible for the study:
Two units of autologous platelets will be collected via an apheresis machine that draws blood from an intravenous (IV) line over 1-2 hours, isolates and leukoreduces the platelets by centrifugation and returns the remaining blood back to the patients. Collected autologous platelets will be stored at 1-6℃ without agitation until they are needed during or after surgery or 14 days have elapsed since their collection, after which they will be destroyed as per standard institutional procedures for expired blood products. For the first two platelet orders within 24 hours of cardiopulmonary bypass (CPB) termination, patients will receive their autologous cold-stored platelets. For the third and subsequent doses, patients in the intervention group will receive allogeneic room temperature-stored platelets (standard of care).
Allogeneic platelets will be collected by Canadian Blood Services as per their standard operating procedures. Room temperature stored platelets will be stored at 20-24°C with constant agitation for up to 7 days as per current practices. For any platelet orders within 24 hours of cardiopulmonary bypass (CPB) termination, patients in the control group will receive allogeneic platelets as per usual care.
Time frame: up to 24 hours after termination of cardiopulmonary bypass (CPB)
The incidence of allogeneic platelet transfusion during the treatment period
Contact information is provided by the study sponsor or research team.
University Health Network, Toronto
Other
Auto-PLTS: The Effectiveness of Autologous, Cold-stored Platelets Collected 7-10 Days Before Cardiac Surgery for Avoidance of Allogeneic Transfusions: A Randomized Patient Preference Trial
Acronym: Auto-PLTS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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