RecruitingPHASE2INTERVENTIONAL

Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial

This study is a pilot, meaning it's a small, initial trial to see if a larger study would be possible. It's looking into a new way of storing blood clotting cells called platelets. Currently, platelets are stored at room temperature, but this trial is testing if keeping them in the fridge (cold-stored) works better for patients with blood cancers who are experiencing bleeding. Many people with blood cancers, especially when having treatments like chemotherapy, face a risk of bleeding. This study will compare how well cold-stored platelets work against the usual room-temperature ones to stop bleeding. The main goal is to recruit 50 patients to understand if this approach is practical and to gather information that will help plan future, bigger studies.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Ottawa Hospital Research Institute

Enrolment target

Start

16 May 2025

Estimated completion

31 Dec 2026

Hematologic Malignancy

What is this study about?

When you have certain blood cancers, like leukaemia or lymphoma, or conditions that affect your bone marrow, your body might not make enough platelets. Platelets are tiny cells that help your blood clot and stop bleeding. Because of this, people with these conditions can be at a higher risk of bleeding, especially when they're having treatments like chemotherapy or a stem cell transplant.

Doctors often give platelet transfusions to help prevent or treat bleeding in these situations. This study is exploring if a new way of storing platelets could make these transfusions even more effective. Currently, platelets are usually stored at room temperature. However, early research suggests that platelets kept in the fridge (cold-stored) might work better at helping blood clot. This small study aims to find out if it's practical to conduct a larger trial comparing cold-stored platelets with the standard room-temperature ones.

The main purpose of this initial study is to recruit 50 people over a year to see how easy it is to run this type of trial and to gather important information. This includes understanding how often patients might need transfusions and how their bleeding changes with each type of platelet. This information will help researchers decide if a larger study is needed and how to best manage the supply of cold-stored platelets in hospitals. It's a step towards potentially finding better ways to help patients with blood cancers manage bleeding.

Key takeaways

This study compares two ways of storing blood clotting cells (platelets) for people with blood cancer.
It's a small pilot study to see if a larger trial is practical.
Patients needing platelet transfusions for bleeding will receive either cold-stored or standard room-temperature platelets.
The goal is to find out if cold-stored platelets are more effective.
Participation involves monitoring during your hospital stay, with no extra visits.

Who may be eligible?

To be considered for this study, you need to be an adult (18 years or older) and currently be in hospital for a blood cancer or a condition where your bone marrow isn't working properly. This includes if you're having chemotherapy, immunotherapy, or a stem cell transplant, or if you're in hospital for managing your symptoms. Your platelet count should be moderately low (between 10 and 100 x10^9/L), and your doctor must have decided that you need a platelet transfusion because you're bleeding.

However, there are some reasons why you might not be able to join. For example, if your platelet count is very low (less than 10 x10^9/L) or if you're already known to need special types of platelets that are matched to your immune system. You also can't take part if you have certain blood clotting problems (shown by specific blood test results) or if you're taking blood-thinning medicines.

Other reasons you might not be eligible include having a known bleeding disorder that you were born with, a history of blood clots that weren't caused by something specific, or if you've recently had a significant platelet transfusion. If you need many platelet transfusions at once, refuse blood transfusions, or are already in another trial that might affect the results of this one, you wouldn't be able to join. Finally, you must be able and willing to understand and agree to take part in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently in hospital for a blood cancer or bone marrow condition and needing a platelet transfusion for bleeding?
Do you have moderate low levels of platelets (not extremely low)?
Are you able to agree to take part in the study?
Are you generally not on special long-term blood-thinning medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue to receive the care and treatments you would normally get for your blood condition. The main difference is that when your doctor decides you need a platelet transfusion to treat bleeding, you will be randomly chosen to receive either platelets stored in the fridge or those stored at room temperature (the standard way). You won't know which type you're getting, and neither will your doctors or nurses.

Researchers will closely monitor your condition, including your bleeding, platelet levels, and any side effects. This will involve regular checks, blood tests, and assessments while you are in the hospital. As this is a pilot study to test how practical it is, you will be observed for a period determined by your hospital stay and need for transfusions. There are no extra hospital visits beyond your normal care, and the goal is to gather information during your existing hospital stay. The study aims to recruit participants over 12 months.

Potential risks and benefits

There's no guarantee that participating in this study will directly benefit you, but the information gathered could help improve treatments for people with blood cancers in the future. You will receive platelet transfusions for bleeding, which is part of your standard care. Potential risks are generally similar to those associated with any platelet transfusion, such as allergic reactions or fever, though these are usually mild. The main difference is whether the platelets are cold-stored or room-temperature stored. There may be unknown risks associated with receiving cold-stored platelets, but early research suggests they may be more effective. You are free to withdraw from the study at any time for any reason, without it affecting your medical care.

Locations (1)

The Ottawa Hospital - General Campus
Verified postcode
Ottawa, Canada· Recruiting

Common questions

What are platelets and why are they important?

Platelets are tiny blood cells that help your blood clot and stop bleeding if you get a cut or bruise. People with blood cancers sometimes don't have enough of them.

What's the main difference in this study?

The study is comparing two ways of storing platelets: keeping them in the fridge (cold-stored) versus the usual way of storing them at room temperature. Both are given as transfusions.

Will I know which type of platelets I'm getting?

No, you won't know whether you're receiving cold-stored or room-temperature stored platelets. This is to ensure fair results for the study.

Why is this study only a 'pilot'?

A pilot study is a small, initial trial to see if a bigger study would be practical and useful. It helps researchers gather information before committing to a larger, more expensive trial.

Can I leave the study at any time?

Yes, you can choose to stop participating in the study at any point, and your medical care will not be affected.

How to find out more

Johnathan M Mack, MD

johnathan.mack.med@ssss.gouv.qc.ca 514-934-1934 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.