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

April 19, 2025 updated by: Donald Arnold

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Recruiting
        • Juravinski Hospital
        • Contact:
        • Contact:
          • Tobias Berg, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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%) .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/LL
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.
Procedure: RBC transfusion strategy
RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/L.
No Intervention: Standard-of-care RBC transfusion strategy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Day 1 to 30
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.
Day 1 to 30
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.
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
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.
Through study completion, an average of 1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 to 30
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.
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
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.
Assessed weekly, from before chemotherapy onset to day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Donald Arnold

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

April 11, 2025

First Submitted That Met QC Criteria

April 19, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 19, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15529

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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