Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding (BAIT)

Donald Arnold

Status: Enrolling

Conditions: Acute Leukemia; Acute Myeloid Leukemia (AML); Acute Lymphocytic Leukaemia

Treatments: Procedure: RBC transfusion strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT06947044

15529

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%) .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/LL

Experimental group

Description:

Participants randomized to this arm will be assigned to a liberal RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/L.

Treatment:

Procedure: RBC transfusion strategy

Standard-of-care RBC transfusion strategy

No Intervention group

Description:

Participants randomized to this arm will be assigned to a restrictive RBC transfusion strategy of standard-of-care, which is typically to maintain a hemoglobin level of at least 70-80 g/L.