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Cold-Stored vs Room Temperature Platelets for Cardiac Surgery (PLTS-1 Trial)

Phase 2

Waitlist Available

Led By Justyna Bartoszko, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned to undergo at least moderately complex surgery or have a preoperative platelet count ≤150,000 x106/L (this is a group at high risk of requiring platelet transfusions post-CPB)

Moderately complex index surgery is defined as: 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year.

Awards & highlights

PLTS-1 Trial Summary

This trial is testing if cold-stored platelets are as effective and safe as conventional platelets in cardiac surgery.

Who is the study for?

This trial is for adults over 18 who need elective cardiac surgery with CPB (heart-lung machine support). It's specifically for those at high risk of bleeding, like patients with low platelet counts or undergoing complex surgeries such as multiple valve repairs or aorta replacement.Check my eligibility

What is being tested?

The PLTS-1 study compares two types of platelet storage methods: cold-stored and room temperature. The goal is to see if cold-stored platelets are just as good at preventing bleeding after heart surgery using CPB as the standard room temp stored ones.See study design

What are the potential side effects?

While specific side effects aren't listed, potential risks may include reactions to transfused platelets, such as fever, allergic reactions, or infections. There might also be issues related to ineffective clotting leading to increased bleeding.

PLTS-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for complex surgery or have a low platelet count.

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I have had a complex heart surgery involving valves or aorta.

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I am 18 or older and scheduled for heart surgery with a heart-lung machine.

PLTS-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility Outcome 1: Adequate Patient Recruitment

Feasibility Outcome 2: Adequate cold-stored platelet supply

Feasibility Outcome 3: Adequate clinician adherence to randomization assignment.

PLTS-1 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

Patients randomized to the Delayed Cold-Stored Platelet Group will receive ABO-identical buffy-coat platelets (pathogen reduced products) maintained at 22°C for up to 4 days then placed at 4°C for a minimum of 1 day (24 hours), with expiration at 14 days after collection.

Group II: Control GroupActive Control1 Intervention

Those randomized to the Room Temperature Platelet Group will receive ABO-identical buffy-coat platelets (pathogen reduced products) maintained at 22°C for up to 7 days (as per current standard of care).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Queen's UniversityOTHER

365 Previous Clinical Trials

120,267 Total Patients Enrolled

University Health Network, TorontoLead Sponsor

1,472 Previous Clinical Trials

484,843 Total Patients Enrolled

Canadian Blood ServicesOTHER

20 Previous Clinical Trials

20,489 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients being accepted into this research endeavor currently?

"According to clinicaltrials.gov, this medical investigation has ceased its recruitment process for the time being; it was initially posted on December 1st 2023 and last modified on November 23rd of that same year. Though participation in this trial is not an option presently, there are 462 other research initiatives globally currently accepting participants."

Answered by AI

What risks could be associated with involvement in the Intervention Group?

"There is some evidence for the safety of Intervention Group, resulting in a score of 2. As this trial only reaches as far as Phase 2 trials, data supporting efficacy has yet to be collected."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Delayed Cold-Stored Platelets -PLTS-1

2024. "Delayed Cold-Stored Platelets -PLTS-1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06147531.