Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding
Recruiting now · Not applicable
Conditions studied: Acute Leukemia, Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukaemia
In brief
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.
Key facts
- Study ID
- NCT06947044
- Run by
- Donald Arnold
- People needed
- 60
- Starts
- 2025-04-11
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2025-04-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥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.
You may not qualify if…
- 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%) .
Where it is running
- Juravinski Hospital — Hamilton, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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