Recruiting PHASE2 Hematologic Malignancy

Compares treatment options for Hematologic Malignancy

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

ClinicalTrials.gov ID: NCT05820126

What this study is testing

What is Cold-stored platelet concentrate?

Cold-stored platelet concentrate is an investigational medicine, being studied as a potential treatment for hematologic malignancy.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This is a pilot trial to discover the feasibility of recruiting 50 pts over the course of 12 months. The trial is testing the efficacy of using cold-stored vs.
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Adult patients (age ≥ 18) admitted to Malignant Hematology ward with hematologic malignancy or marrow aplasia, this may include patients undergoing...
  • Moderate thrombocytopenia, platelet concentration 10-100 x109/L
  • Platelet transfusion ordered to treat bleeding

You likely can't join if

  • Severe thrombocytopenia (platelet concentration \<10 x 109/L)
  • Known platelet refractoriness requiring HLA or HPA selected platelet concentrates
  • International normalized ratio (INR) \>2.0
  • Activated partial thromboplastin time (aPTT) \>40 seconds
  • Therapeutic anticoagulation (unfractionated heparin, low molecular weight heparin, warfarin, direct oral anticoagulant)
  • Known congenital bleeding disorder
See the full eligibility criteria
Who can join
  • Adult patients (age ≥ 18) admitted to Malignant Hematology ward with hematologic malignancy or marrow aplasia, this may include patients undergoing chemotherapy, immunotherapy, or hematopoietic stem cell transplant or...
  • Moderate thrombocytopenia, platelet concentration 10-100 x109/L
  • Platelet transfusion ordered to treat bleeding
What rules you out
  • Severe thrombocytopenia (platelet concentration \<10 x 109/L)
  • Known platelet refractoriness requiring HLA or HPA selected platelet concentrates
  • International normalized ratio (INR) \>2.0
  • Activated partial thromboplastin time (aPTT) \>40 seconds
  • Therapeutic anticoagulation (unfractionated heparin, low molecular weight heparin, warfarin, direct oral anticoagulant)
  • Known congenital bleeding disorder
  • History of unprovoked venous thromboembolic disease
  • Transfusion of platelet concentrate for \>grade 2 bleeding in preceding 24 hours
  • Order for multiple platelet transfusion at once
  • Refusal of blood transfusion
  • Prior participation in CoVeRTS-HM trial
  • Participation in other clinical trials with interventions that may affect CoVeRTS-HM treatment or outcome
  • Unable or unwilling to provide informed consent

The study team makes the final eligibility decision.

Where it's taking place

  • Ottawa, Ontario, Canada

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.