Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding
Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding (BAIT): A Pilot Study
Donald Arnold
60 participants
Apr 11, 2025
INTERVENTIONAL
Conditions
Summary
This pilot study aims to gather preliminary evidence on how different hemoglobin levels impact blood biomarkers related to bleeding. The feasibility of conducting a future larger clinical trial will also be assessed. Red blood cell transfusions are part of the standard of care for patients with leukemia. This study evaluates two transfusion strategies: one that maintains hemoglobin levels above the standard-of-care threshold, reflecting current routine practice; and another that maintains hemoglobin levels above 110 g/L, which is closer to the normal hemoglobin range. The normal hemoglobin range is 120-160 g/L for females and 140-180 g/L for males. Raising hemoglobin levels closer to normal values may reduce bleeding risk.
Eligibility
Inclusion Criteria5
- ≥18 years old.
- Inpatient
- Diagnosis of acute myeloid leukemia or acute lymphocytic leukemia.
- Less than 5 days have elapsed since the start of induction chemotherapy treatment.
- Hemoglobin at enrolment is under 130 g/L.
Exclusion Criteria9
- Failure to provide informed consent.
- Unwilling to receive blood transfusions.
- Life expectancy \<72 hours.
- Undergoing palliative chemotherapy.
- Requires specialized blood products (e.g., antigen-matched, irradiation, etc.).
- Diagnosis of acute promyelocytic leukemia.
- Diagnosis of hyperleukocytosis (a white blood cell count exceeding 100 × 10\^9/L).
- 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)
- Evidence of iron overload (ferritin \>800 ng/mL, transferrin saturation \>80%) .
Interventions
RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/L.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06947044