Evaluating hemoglobin levels and bleeding risk in leukemia patients
Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding (BAIT): A Pilot Study
This study is testing how different hemoglobin levels affect bleeding risk in people with acute leukemia to see which red blood cell transfusion strategy works better for their care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT06947044 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates how varying hemoglobin levels affect blood biomarkers associated with bleeding in patients with acute leukemia. It compares two red blood cell transfusion strategies: one that maintains hemoglobin levels above the standard threshold and another that aims for levels closer to normal. The study also assesses the feasibility of conducting a larger clinical trial based on the preliminary findings. By understanding the relationship between hemoglobin levels and bleeding risk, the study aims to improve patient care in leukemia treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with acute myeloid leukemia or acute lymphocytic leukemia who are currently hospitalized and have low hemoglobin levels.
Not a fit: Patients who are unwilling to receive blood transfusions or have a life expectancy of less than 72 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved transfusion strategies that reduce bleeding risks in leukemia patients.
How similar studies have performed: While this approach is novel in the context of leukemia, similar studies in other conditions have shown promising results regarding the impact of hemoglobin levels on bleeding risk.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥18 years old. 2. Inpatient 3. Diagnosis of acute myeloid leukemia or acute lymphocytic leukemia. 4. Less than 5 days have elapsed since the start of induction chemotherapy treatment. 5. Hemoglobin at enrolment is under 130 g/L. Exclusion Criteria: 1. Failure to provide informed consent. 2. Unwilling to receive blood transfusions. 3. Life expectancy \<72 hours. 4. Undergoing palliative chemotherapy. 5. Requires specialized blood products (e.g., antigen-matched, irradiation, etc.). 6. Diagnosis of acute promyelocytic leukemia. 7. Diagnosis of hyperleukocytosis (a white blood cell count exceeding 100 × 10\^9/L). 8. Diagnosed with coagulopathies or ongoing treatment with therapeutic anticoagulants, aspirin or nonsteroidal anti-inflammatory drugs (history of inherited or acquired coagulation disorder, known hemolytic disease, INR \> 1.5) 9. Evidence of iron overload (ferritin \>800 ng/mL, transferrin saturation \>80%) .
Where this trial is running
Hamilton, Ontario
- Juravinski Hospital — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Dimpy Modi
- Email: modid1@mcmaster.ca
- Phone: 905-525-9140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.