Autologous Cold-stored Apheresis Platelets
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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.
Eligibility criteria
Qualifiers
Repair or replacement of more than one valve (i.e., multiple valves)
Repair or replacement of any segment of aortic arch
At least two of any combination of coronary artery bypass grafting (CABG), valve repair/replacement, or aorta (ascending/arch) repair/replacement
Complex adult congenital repair
Disqualifiers
Seven days or less from recruitment to surgery (as there will not be sufficient time from platelet donation to surgery for patients to recover their platelet count)
Poor intravenous access
Low baseline platelet count (≤150,000 x106/L)
Low baseline hemoglobin (<100 g/L) (since approximately 50 mL of red blood cells are lost with each unit of apheresis platelet collection)
Trial design
Treatments tested in this trial
- Autologous Cold-Stored Platelets
- Allogeneic Room Temperature-Stored Platelets (Standard of Care)
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov