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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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