Autologous Cold-Stored Platelets for Cardiac Surgery

(Auto-PLTS Trial)

Overseen By Deep Grewal

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University Health Network, Toronto

Must not be taking: Anticoagulants, Antiplatelets, NSAIDs

Disqualifiers: Low platelet count, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using platelets (blood cells that help stop bleeding) in patients undergoing heart surgery. The researchers aim to determine if using a patient’s own platelets, stored in a special way (autologous cold-stored apheresis platelets), can improve recovery and reduce reliance on donated blood supplies. The trial compares outcomes between those using their own platelets and those using standard donated platelets. Individuals planning complex heart surgery who can donate their own platelets a week before surgery may be suitable candidates for this trial. As a Phase 2, Phase 3 trial, it evaluates the treatment's effectiveness in a smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in heart surgery.

Will I have to stop taking my current medications?

If you are on any anticoagulant or antiplatelet medications, except for ASA (aspirin), you will need to stop them at least 7 days before donating platelets for the trial. NSAIDs (non-steroidal anti-inflammatory drugs) need to be stopped 72 hours before donation.

Is there any evidence suggesting that autologous cold-stored apheresis platelets are likely to be safe for humans?

Research has shown that storing platelets in the cold might be safer than keeping them at room temperature. Studies have found that cold storage lowers the chances of bacterial contamination, reducing the risk of infections during transfusions. This is especially important during surgeries where platelets help stop bleeding.

For autologous (self-donated) platelets, patients receive their own platelets, collected and stored cold before surgery. This approach reduces the risk of reactions that can occur with donor platelets. Although specific data on autologous cold-stored platelets is limited, the overall safety of cold-stored platelets appears promising.

Regarding side effects, current data suggest that cold-stored platelets are generally well-tolerated. Ongoing research into these treatments shows their potential to improve patient outcomes by reducing complications related to platelet transfusions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard care for cardiac surgery, which involves using allogeneic platelets from donors, the treatment being studied uses autologous cold-stored apheresis platelets. This means patients receive their own platelets, collected before surgery and stored at a cool temperature, which could minimize the risk of immune reactions and infections associated with donor platelets. Additionally, the cold storage method may enhance the platelets' effectiveness in clotting, potentially leading to better outcomes in controlling bleeding during surgery. Researchers are excited about this approach because it offers a personalized and possibly safer alternative to current practices.

What evidence suggests that autologous cold-stored apheresis platelets might be an effective treatment for cardiac surgery?

Research has shown that using a patient's own platelets, stored at cold temperatures, might improve outcomes for those undergoing heart surgery. In this trial, participants in the intervention group will receive their own autologous cold-stored platelets during or after surgery. Studies have found that these platelets can reduce the need for additional blood transfusions. In heart surgeries, where bleeding is a concern, these cold-stored platelets enhance blood clotting. Previous findings suggest they might also aid recovery by maintaining higher platelet levels after surgery. This method could reduce the need for donor blood, benefiting the healthcare system. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

The trial is for patients scheduled for elective cardiac surgery at Toronto General Hospital, who are willing to donate their own platelets 7-10 days before the operation. It's not specified who can't join, but typically those with conditions affecting blood donation or platelet function might be excluded.

Inclusion Criteria

* 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Preadmission and Autologous Platelet Collection

Patients undergo autologous collection of 2 units of apheresis platelets 7-10 days before surgery during their preadmission visit

1 week

1 visit (in-person)

Surgery and Treatment

Patients receive either autologous or allogeneic platelets during or after surgery in response to excessive bleeding

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Cold-stored Apheresis Platelets

Trial Overview This study compares two types of platelet transfusions: standard room temperature-stored allogeneic (donor) platelets versus autologous cold-stored platelets donated by the patients themselves prior to surgery. The goal is to see if using one's own stored platelets leads to better outcomes and helps conserve donor supplies.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Patients in the intervention group will undergo autologous collection of 2 units of apheresis platelets 7-10 days before surgery during their preadmission visit. 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.

Group II: Control Group Active Control 1 Intervention

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 Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07064954

NCT07064954 | Autologous Cold-stored Apheresis Platelets The Auto-PLTS Study is designed to assess whether replacing allogeneic platelets with autologous platelets will improve patient outcomes and benefit the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524875/

Postoperative Transfusions following Administration ... In adults undergoing cardiac surgery, delayed cold-stored platelets were associated with higher postoperative transfusion utilization and lower platelet counts ...

3. ctv.veeva.com ctv.veeva.com/study/extended-cold-stored-apheresis-platelets-in-cardiac-surgery-patients

Extended Cold Stored Apheresis Platelets in Cardiac Surgery ... Patients who undergo re-exploration due to excessive bleeding have a 2-6 fold increased mortality compared with non-bleeding patients. Storage ...

4. ashpublications.org ashpublications.org/blood/article/146/17/2023/546600/Chilling-controversy-cold-stored-platelets-for

cold-stored platelets for prophylactic transfusions | Blood In a recent study from our group, CSPs were superior to RTPs in promoting thrombin formation after transfusion in vivo.19 When extending the storage times ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/13/6/e073341

Efficacy of autologous plateletpheresis in adult aortic surgery This study aims to evaluate the efficacy of APC as a blood conservation technique to reduce blood transfusion in adult aortic surgery.

6. withpower.com withpower.com/trial/phase-2-and-3-platelets-8-2025-c8b28

Autologous Cold-Stored Platelets for Cardiac Surgery The Auto-PLTS Study is designed to assess whether replacing allogeneic platelets with autologous platelets will improve patient outcomes and benefit the ...