BleedingPhase 2/3Auto-PLTSNCT07064954
Autologous Cold-stored Apheresis Platelets
A Phase 2/3 study testing Autologous Cold-Stored Platelets in people with Bleeding and Platelets, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding, Platelets, Cardiopulmonary Bypass
- What is being tested?
- Autologous Cold-Stored Platelets
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 28 Sep 2026to 30 Apr 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 years old) patients who meet all following criteria:
- 1. Undergoing elective complex cardiac surgery consisting of at least one of the following:
- 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
Who cannot join
- Patients who meet any of the following criteria are not eligible for the study:
- 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)
- Patient factors that preclude platelet donation or increase risk of adverse events after donation, including any of the following:
- 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)
Show all 15Show fewer
- Inability to tolerate fluid shifts during donation (i.e., severe aortic stenosis with valve area <0.7 cm2, or left main coronary artery stenosis >80%, or left ventricular ejection fraction <30%)
- Increased risk of bacterial contamination of collected units (i.e., active infection, on antibiotics, dental procedure <72 hours before donation)
- Attending clinicians deem the patient ineligible for autologous predonation
- Known positivity for active infectious blood-borne disease (HIV, HCV, HBV, HTLV, Syphilis)
- Highly specialized procedures such as insertion or removal of ventricular assist devices or repair of thoracoabdominal aneurysm
- Any history of congenital or acquired bleeding disorder (including any type of thrombocytopenia or platelet refractoriness due to anti-platelet and anti-HLA antibodies or requirement for specially matched platelets)
- On any anticoagulant or antiplatelet medications, excluding ASA, that cannot be stopped at least 7 days before donation (72 hours for NSAIDs)
- Refusal of allogeneic blood products due to religious or other reasons
- Known or suspected pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital - University Health Network
Toronto, Ontario, M5G 2C4
Justyna Bartoszko, MD MSc FRCPC, (416) 340-4800 ext. 3243, Justyna.Bartoszko@uhn.ca
Justyna Bartoszko, MD MSc FRCPC
About this study
Official title: 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
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.
- Conditions
- Bleeding, Platelets, Cardiopulmonary Bypass, Cardiac Surgery
- Being tested
- Autologous Cold-Stored Platelets, Allogeneic Room Temperature-Stored Platelets (Standard of Care)
- Keywords
- Autologous Blood Donation
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Cold-Stored PlateletsBiological
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 Room Temperature-Stored Platelets (Standard of Care)Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients in the intervention group will undergo autologous collection of 2 units of apheresis platelets 7-10 days before surgery. The collected autologous platelets will be cold-stored at 1-6°C until the time of surgery. Patients will receive their own autologous platelets during or after surgery in response to excessive bleeding in the setting of low platelet count or function. Receives: Biological: Autologous Cold-Stored Platelets |
| Control Group | Active comparator | Patients in the control group will receive standard, Health Canada approved, allogeneic platelets supplied by the Canadian Blood Services (stored at room temperature for up to 7 days) during or after surgery in response to excessive bleeding in the setting of low platelet count or function. Receives: Biological: Allogeneic Room Temperature-Stored Platelets (Standard of Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint
The incidence of allogeneic platelet transfusion during the treatment period
Measured: up to 24 hours after termination of cardiopulmonary bypass (CPB)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start28 Sep 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Auto-PLTS is a single-centre trial that uses a randomized, patient preference design. Patients who agree to participate in the randomization stream will be assigned to the two study arms by random allocation. Those who do not consent to randomization but agree to participate in the patient preference stream will be assigned to their preferred arm of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064954
- Sponsor's protocol ID
- 24-5285
- Acronym
- Auto-PLTS
- Status last verified
- Sep 2026
- First submitted
- 7 Jul 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07064954
- Acronym / sponsor ID
- Auto-PLTS / 24-5285
- Conditions
- Bleeding, Platelets, Cardiopulmonary Bypass, Cardiac Surgery
- Keywords
- Autologous Blood Donation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Auto-PLTS is a single-centre trial that uses a randomized, patient preference design. Patients who agree to participate in the randomization stream will be assigned to the two study arms by random allocation. Those who do not consent to randomization but agree to participate in the patient preference stream will be assigned to their preferred arm of the study.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Biological: Autologous Cold-Stored PlateletsPatients in the intervention group will undergo autologous collection of 2 units of apheresis platelets 7-10 days before surgery. The collected autologous platelets will be cold-stored at 1-6°C until the time of surgery. Patients will receive their own autologous platelets during or after surgery in response to excessive bleeding in the setting of low platelet count or function. |
| Control Group | Active comparator | Biological: Allogeneic Room Temperature-Stored Platelets (Standard of Care)Patients in the control group will receive standard, Health Canada approved, allogeneic platelets supplied by the Canadian Blood Services (stored at room temperature for up to 7 days) during or after surgery in response to excessive bleeding in the setting of low platelet count or function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Undergoing elective complex cardiac surgery consisting of at least one of the following:
- 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
Key exclusion criteria (15 listed)
- 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)
- Patient factors that preclude platelet donation or increase risk of adverse events after donation, including any of the following:
- Highly specialized procedures such as insertion or removal of ventricular assist devices or repair of thoracoabdominal aneurysm
- Any history of congenital or acquired bleeding disorder (including any type of thrombocytopenia or platelet refractoriness due to anti-platelet and anti-HLA antibodies or requirement for specially matched platelets)
- On any anticoagulant or antiplatelet medications, excluding ASA, that cannot be stopped at least 7 days before donation (72 hours for NSAIDs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Cold-Stored PlateletsTwo 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). | Biological | Intervention Group |
| 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. | Biological | Control Group |
Primary outcome
Primary Efficacy Endpoint
Time frame: up to 24 hours after termination of cardiopulmonary bypass (CPB)
The incidence of allogeneic platelet transfusion during the treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Autologous Cold-Stored Platelets in people with Bleeding and Platelets, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keyvan Karkouti, MD (416-340-4800 ext. 4221, ACTU@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint (time frame: up to 24 hours after termination of cardiopulmonary bypass (CPB)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.