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Recruiting NCT06947044

Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding

No phase Interventional Acute Leukemia Acute Myeloid Leukemia (AML) Acute Lymphocytic Leukaemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RBC transfusion strategy.
Who it may be relevant to
Registry conditions: Acute Leukemia, Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukaemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding (BAIT): A Pilot Study

Overview

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.

Interventions

  • Procedure RBC transfusion strategy
    RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/L.

Primary outcome measures

  • Effect of maintaining a higher hemoglobin level (110 g/L) compared with the standard hemoglobin level on bleeding-related biomarkers. [Time frame: Samples will be collected before chemotherapy onset, and on days 7, 14, and 28. The first day of chemotherapy is considered day 1]
  • Protocol adherence to the study intervention (feasibility outcome) [Time frame: Day 1 to 30]
  • Protocol adherence to the study schedule (feasibility outcome) [Time frame: Day 1 to 30]
  • Consent rate (feasibility outcome) [Time frame: Through study completion, an average of 1.5 years]
  • Screen failure rate (feasibility outcome) [Time frame: Through study completion, an average of 1.5 years]
Secondary outcome measures (3)
  • The total number of blood products administered to participants in the liberal and standard arms of the study [Time frame: Day 1 to 30]
  • The association between the hemoglobin threshold used and bleeding events [Time frame: Day 1 to 30]
  • The association between the hemoglobin threshold used and quality-of-life [Time frame: Assessed weekly, from before chemotherapy onset to day 28]

Eligibility criteria

Inclusion criteria

  • ≥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 criteria

  • 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%) .

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Juravinski Hospital — Hamilton

Identifiers

NCT: NCT06947044 · 15529

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗