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NCT Number: NCT06947044

Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding

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.

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Key information

Conditions

Acute Leukemia Acute Lymphocytic Leukaemia Acute Myeloid Leukemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location status: Recruiting

Location contact

Dimpy Modi

CONTACT

[email protected]

Tobias Berg, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%) .

Treatment and study plan

RBC transfusion strategy

Procedure

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

Primary outcomes

  1. 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

    Blood and urine samples will be taken from participants at selected timepoints to measure levels of biomarkers from the endothelial integrity, inflammation, and fibrinolysis/coagulation domains.

  2. Protocol adherence to the study intervention (feasibility outcome)

    Time frame: Day 1 to 30

    The total number of days where hemoglobin levels were above the assigned threshold or days where RBCs were administered when the hemoglobin level was reported to be below that threshold.

  3. Protocol adherence to the study schedule (feasibility outcome)

    Time frame: Day 1 to 30

    Measurement of how consistently participants and study staff follow the prescribed schedule for study assessments and sample collections as outlined in the study protocol. Measurements include percentage of scheduled biomarker testing days with data collected, percentage of non-weekday study days with completed bleeding assessments, and percentage of scheduled study days with completed FACT questionnaires.

  4. Consent rate (feasibility outcome)

    Time frame: Through study completion, an average of 1.5 years

    The proportion of potential participants who agree to participate in the study.

  5. Screen failure rate (feasibility outcome)

    Time frame: Through study completion, an average of 1.5 years

    The proportion of participants who are screened for eligibility but do not meet the study's inclusion and exclusion criteria and are therefore not enrolled in the trial.

Secondary outcomes

  1. 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 number of platelet and red blood cell units administered to each participant will be summed and compared between study groups.

  2. The association between the hemoglobin threshold used and bleeding events

    Time frame: Day 1 to 30

    Comparison of the time-to-bleed data between the study groups.

  3. The association between the hemoglobin threshold used and quality-of-life

    Time frame: Assessed weekly, from before chemotherapy onset to day 28

    The FACIT-Thrombocytopenia scale will be used to score participants between 0 (worst quality of life) and 52 (best quality of life). Higher scores indicate better quality of life, and less impact of symptoms related to thrombocytopenia.

Study contacts

Contact information is provided by the study sponsor or research team.

Dimpy Modi

CONTACT

[email protected]

905-525-9140 ext. 26512

Sponsors and collaborators

Lead sponsor

Donald Arnold

Other

Registry information

Official study title

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

Acronym: BAIT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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