Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding
NCT06947044
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 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%) .
Conditions4
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NCT06947044