Clinical trial NCT06947044: Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding
Official title: Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding (BAIT): A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Leukemia
Acute Myeloid Leukemia (AML)
Acute Lymphocytic Leukaemia
Keywords: transfusion
red blood cells
hemoglobin level
bleeding
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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%) .

Primary outcomes:
measure: Effect of maintaining a higher hemoglobin level (110 g/L) compared with the standard hemoglobin level on bleeding-related biomarkers.
timeFrame: Samples will be collected before chemotherapy onset, and on days 7, 14, and 28. The first day of chemotherapy is considered day 1
measure: Protocol adherence to the study intervention (feasibility outcome)
timeFrame: Day 1 to 30
measure: Protocol adherence to the study schedule (feasibility outcome)
timeFrame: Day 1 to 30
measure: Consent rate (feasibility outcome)
timeFrame: Through study completion, an average of 1.5 years
measure: Screen failure rate (feasibility outcome)
timeFrame: Through study completion, an average of 1.5 years
Secondary outcomes:
measure: The total number of blood products administered to participants in the liberal and standard arms of the study
timeFrame: Day 1 to 30
measure: The association between the hemoglobin threshold used and bleeding events
timeFrame: Day 1 to 30
measure: The association between the hemoglobin threshold used and quality-of-life
timeFrame: Assessed weekly, from before chemotherapy onset to day 28
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
Study officials:
References: