Acute LeukemiaBAITNCT06947044
Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding
A study testing RBC transfusion strategy in people with Acute Leukemia and Acute Myeloid Leukemia (AML), run by Donald Arnold at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia, Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukaemia
- What is being tested?
- RBC transfusion strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 11 Apr 2025to 1 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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.
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- 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%) .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- RBC transfusion strategy
- Keywords
- transfusion, red blood cells, hemoglobin level, bleeding
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBC transfusion strategyProcedure or surgery
RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/L.
| Study group | Role | What they receive |
|---|---|---|
| RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/LL | Experimental | 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. Receives: Procedure: RBC transfusion strategy |
| Standard-of-care RBC transfusion strategy | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Effect of maintaining a higher hemoglobin level (110 g/L) compared with the standard hemoglobin level on bleeding-related biomarkers.
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.
Measured: 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)
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.
Measured: Day 1 to 30
Protocol adherence to the study schedule (feasibility outcome)
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.
Measured: Day 1 to 30
Consent rate (feasibility outcome)
The proportion of potential participants who agree to participate in the study.
Measured: Through study completion, an average of 1.5 years
Screen failure rate (feasibility outcome)
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.
Measured: Through study completion, an average of 1.5 years
Secondary outcomes (3)
The total number of blood products administered to participants in the liberal and standard arms of the study
The number of platelet and red blood cell units administered to each participant will be summed and compared between study groups.
Measured: Day 1 to 30
The association between the hemoglobin threshold used and bleeding events
Comparison of the time-to-bleed data between the study groups.
Measured: Day 1 to 30
The association between the hemoglobin threshold used and quality-of-life
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.
Measured: Assessed weekly, from before chemotherapy onset to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start11 Apr 2025
- Primary completion31 Aug 2026
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Donald Arnold
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Donald Arnold, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947044
- Sponsor's protocol ID
- 15529
- Acronym
- BAIT
- Status last verified
- Oct 2026
- First submitted
- 11 Apr 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided