NCT06947044 Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding
| NCT ID | NCT06947044 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Donald Arnold |
| Condition | Acute Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-11 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-04-11 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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%) .
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06947044 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06947044 currently recruiting?
Yes, NCT06947044 is actively recruiting participants. Contact the research team at modid1@mcmaster.ca for enrollment information.
Where is the NCT06947044 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT06947044 clinical trial?
NCT06947044 is sponsored by Donald Arnold. The trial plans to enroll 60 participants.
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