Delayed Cold-Stored Platelets -PLTS-1
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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.
Eligibility criteria
Qualifiers
repair/replacement of more than one valve;
aorta (root/ascending/arch) replacement;
any combination of coronary artery bypass grafting, valve repair/replacement, or aorta (root/ascending/arch) replacement; or
re-do procedures consisting of a repair or revision of a prior cardiac intervention.
Disqualifiers
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),
has known contraindications to heparin, thereby excluding cases where non-reversible anticoagulants (i.e. argatroban) are used,
is on warfarin or direct oral anticoagulants (dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to surgery,
is on antiplatelet drugs within 5 days prior to surgery (excluding acetylsalicylic acid [ASA]),
Trial design
Treatments tested in this trial
- Delayed Cold-Stored Buffy Coat Platelets
- Room Temperature Buffy Coat Platelets
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Health Network, Toronto
Lead sponsor
Kingston Health Sciences Centre
Collaborator
Canadian Blood Services
Collaborator
Source ClinicalTrials.gov