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NCT06947044Active, not recruiting

Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding

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

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
11 Apr 2025
Start date
11 Apr 2025
Primary completion date
31 Aug 2026
Lead sponsor
Donald Arnold
NCT number
NCT06947044

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 11 Apr 2025 to the primary completion date, 31 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Undergoing palliative chemotherapy.
  • Requires specialized blood products (e.g., antigen-matched, irradiation, etc.).

Other illness

  • Failure to provide informed consent.

Lab values

  • 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)

Other

  • Unwilling to receive blood transfusions.
  • Life expectancy \<72 hours.
  • Diagnosis of acute promyelocytic leukemia.
  • Evidence of iron overload (ferritin \>800 ng/mL, transferrin saturation \>80%) .

Who the study is looking for

  • ≥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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Juravinski Hospital
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.