Cold vs Room Temperature Platelet Transfusions for Cardiac Surgery Patients

(CHIPS Trial)

Recruiting at 33 trial locations

Overseen By Brian Kirchhoff

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Philip Spinella

Disqualifiers: Pregnancy, IgA deficiency, congenital disorders, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

A phase 3 randomized partial blind storage duration ranging study in patients undergoing complex cardiac surgery that will compare the transfusion of cold stored platelets to standard room temperature stored platelets. The primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

Is it safe to use cold stored platelets in humans?

Research suggests that cold stored platelets (CSP) are generally safe for use in humans, with benefits like reduced bacterial contamination and longer shelf life compared to room temperature platelets (RTP). CSPs have been shown to be effective in reducing bleeding and restoring platelet function, similar to RTPs. ^{1 2 3 4 5}

How do cold stored platelets differ from room temperature platelets in cardiac surgery patients?

Cold stored platelets (CSP) are kept at a cooler temperature (1-6°C) compared to room temperature platelets (RTP) which are stored at 20-24°C. CSP have superior clotting abilities, making them more effective for treating active bleeding, while RTP are better for increasing platelet count in non-bleeding patients. CSP also have a longer shelf life, reducing waste and potentially improving availability. ^{1 2 3 6 7}

What data supports the effectiveness of cold stored platelets for cardiac surgery patients?

Research suggests that cold stored platelets (CSP) are better at stopping bleeding compared to room temperature platelets (RTP), which is important for patients undergoing cardiac surgery. CSPs also have a longer shelf life and reduced risk of bacterial contamination, making them a promising option for managing bleeding in these patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Philip C Spinella, MD

Principal Investigator

University of Pittsburgh

Marie E Steiner, MD

Principal Investigator

University of Minnesota

Nicole D Zantek, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

The CHIPS trial is for patients aged between 28 days and less than 85 years who are scheduled for complex cardiac surgery with cardiopulmonary bypass. It's not suitable for those expecting to receive whole blood, have known platelet issues, are pregnant or previously in the study, among other specific health conditions.

Inclusion Criteria

I am scheduled for a complex heart surgery that will use a heart-lung machine.

I am older than 28 days and younger than 85 years.

Exclusion Criteria

Known IgA deficiency

My platelet count is below 75,000 based on recent tests before surgery.

I am scheduled for ECMO, VAD, or dialysis after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transfusions of either cold stored or room temperature stored platelets during complex cardiac surgery

1 week

In-hospital stay for surgery and transfusion

Follow-up

Participants are monitored for transfusion associated adverse events and other outcomes

4 weeks

Regular follow-up visits and monitoring

Long-term follow-up

Participants are monitored for all-cause mortality and other long-term outcomes

up to 28 days

What Are the Treatments Tested in This Trial?

Interventions

• Cold Stored Platelets
• Room Temperature Platelets

Trial Overview This phase 3 trial compares cold stored platelets to standard room temperature stored ones in patients having complex heart surgery. The goal is to see if cold platelets work as well as or better than the standard treatment when transfused.

How Is the Trial Designed?

Group I: Cold Stored Platelets Experimental Treatment 1 Intervention

Platelets stored at 1-6 degree Celsius

Group II: Room Temperature Platelets Active Control 1 Intervention

Platelets stored at 20-24 degrees Celsius

Cold Stored Platelets is already approved in United States for the following indications:

Approved in United States as Cold Stored Platelets for:

• Active bleeding when conventional platelets are not available or their use is not practical

Who Is Running the Clinical Trial?

Philip Spinella

Lead Sponsor

Trials

2

Recruited

2,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

Cold-stored platelets (CSP) have been shown to maintain better hemostatic function and adhesion properties compared to standard room-temperature platelets (RTP), making them potentially more effective for patients undergoing cardiac surgery.

CSP also offer advantages such as a longer shelf-life and a lower risk of bacterial contamination, but further large clinical trials are necessary to confirm their benefits in treating acute bleeding situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cold-stored platelets for acute bleeding in cardiac surgical patients: a narrative review. Lu, J., Karkouti, K., Peer, M., et al.[2023]

Cold stored platelets (CSP) are more effective in reducing bleeding in actively bleeding patients, while room temperature platelets (RTP) are better for increasing platelet counts in those needing prophylactic transfusions, highlighting the clinical benefits of maintaining both types.

A simulation study showed that while having CSP can help reduce product shortages, it does not significantly decrease wastage of RTP, suggesting that the operational costs of maintaining both inventories may not be offset by reduced wastage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The operational impact of introducing cold stored platelets. Blake, JT., Krok, E., Pavenski, K., et al.[2023]

This study found that cold-stored platelets (CSPs) showed significant quality differences compared to room temperature-stored platelets (RTPs), including reduced concentration and increased activation markers over a 7-day storage period.

Donor body mass index (BMI) significantly affected platelet quality, with higher BMI donors exhibiting lower platelet concentrations and activation responses, indicating the need for new quality markers for CSP assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of donor biological variation on the quality and function of cold-stored platelets. Lorusso, A., Croxon, H., Faherty-O'Donnell, S., et al.[2023]

Cold stored platelets (CSP) have been shown to provide equivalent hemostatic benefits and restore platelet function just as effectively as room temperature platelets (RTP), while also reducing risks of bacterial contamination and wastage.

Despite the advantages of CSP, its production and use in clinical settings remain low, highlighting the need for strategies to improve its implementation in blood centers and hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cold stored platelets - Increasing understanding and acceptance. Gammon, RR., Hebert, J., Min, K., et al.[2023]

Cold-stored platelets (CS-PLTs) were approved for use in actively bleeding trauma patients, with initial FDA approval for a 3-day storage period without agitation, highlighting their potential for improved hemostatic outcomes compared to room temperature platelets.

Despite the approval, a high discard rate of 80.9% was observed due to clot formation during storage, indicating a need for advancements like pathogen-reduced solutions to extend shelf life and reduce contamination risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cold platelets for trauma-associated bleeding: regulatory approval, accreditation approval, and practice implementation-just the "tip of the iceberg". Stubbs, JR., Tran, SA., Emery, RL., et al.[2018]

Platelet transfusions are crucial in medicine, but current storage methods at room temperature limit shelf life to 5-7 days, leading to high wastage and availability issues, especially in remote areas.

Recent studies suggest that cryopreserved and cold-stored platelets can provide a pro-coagulant profile, potentially offering a rapid hemostatic response in bleeding patients, making them a promising alternative for blood banks to consider.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frozen and cold-stored platelets: reconsidered platelet products. Jimenez-Marco, T., Castrillo, A., Hierro-Riu, F., et al.[2022]

Cold-stored platelets and delayed-cold platelets (stored at room temperature for 4 days before refrigeration) maintained similar platelet counts and activation profiles over a 21-day period, indicating that delayed-cold storage could be a practical alternative.

Transferring platelets to refrigerated storage near their expiry date may help maximize platelet inventories without compromising their quality, making it a potential strategy for managing platelet supplies effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximising platelet availability by delaying cold storage. Wood, B., Johnson, L., Hyland, RA., et al.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Cold-stored platelets for acute bleeding in cardiac surgical patients: a narrative review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The operational impact of introducing cold stored platelets. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The impact of donor biological variation on the quality and function of cold-stored platelets. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Cold stored platelets - Increasing understanding and acceptance. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Cold platelets for trauma-associated bleeding: regulatory approval, accreditation approval, and practice implementation-just the "tip of the iceberg". [2018]

6. England pubmed.ncbi.nlm.nih.gov

Frozen and cold-stored platelets: reconsidered platelet products. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Maximising platelet availability by delaying cold storage. [2019]