Actively Recruiting
Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding (BAIT): A Pilot Study
Led by Donald Arnold · Updated on 2025-04-27
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand how different hemoglobin levels affect blood markers related to bleeding in patients with acute leukemia. It evaluates two red blood cell transfusion strategies: one maintaining hemoglobin above the standard threshold used in routine care, and another targeting a higher level closer to normal hemoglobin values. The study also explores the feasibility of running a larger clinical trial in the future to further investigate these effects. Participants will be randomly assigned to one of two groups. One group will receive transfusions to keep their hemoglobin level at least 110 g/L, while the other group will follow the standard care transfusion strategy, maintaining hemoglobin at about 70-80 g/L. These strategies will be carried out during the first month after the start of induction chemotherapy, with blood samples taken before chemotherapy and on days 7, 14, and 28 to study bleeding-related biomarkers. During the study, participants will be closely monitored for adherence to the transfusion protocol and schedule over 30 days. Researchers will collect blood samples and measure bleeding risk markers, the number of transfusions given, bleeding events, and quality of life weekly from before chemotherapy through day 28. Consent rates and screen failure rates will also be tracked over an average of 1.5 years to assess how feasible the study design is for future trials.
CONDITIONS
Brief Title
Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Currently an inpatient
- Diagnosed with acute myeloid leukemia or acute lymphocytic leukemia
- Started induction chemotherapy less than 5 days ago
- Hemoglobin level below 130 g/L at enrollment
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Unwilling to receive blood transfusions
- Life expectancy less than 72 hours
- Receiving palliative chemotherapy
- Need for specialized blood products like antigen-matched or irradiated blood
- Diagnosis of acute promyelocytic leukemia
- Diagnosis of hyperleukocytosis (white blood cell count over 100 x 10^9/L)
- Diagnosed with coagulopathies or currently treated with therapeutic anticoagulants, aspirin, or NSAIDs
- Evidence of iron overload (ferritin over 800 ng/mL or transferrin saturation over 80%)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants receive RBC transfusions to maintain hemoglobin levels as per their assigned transfusion strategy during induction chemotherapy.
Weekly visits up to 4 weeks
Duration - Up to 28 days
Participants are monitored for bleeding-related biomarkers, blood product use, and quality of life through day 28 after starting chemotherapy.
Visits on days 7, 14, and 28
Trial Site Locations
Total: 1 location
1
Juravinski Hospital
Hamilton, Ontario, Canada, L8V 1C3
Actively Recruiting
Research Team
D
Dimpy Modi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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