Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding
Launched by DONALD ARNOLD · Apr 19, 2025
Trial Information
Current as of July 12, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how different levels of hemoglobin in the blood affect bleeding in patients with acute leukemia, specifically acute myeloid leukemia (AML) and acute lymphocytic leukemia. Hemoglobin is a protein in red blood cells that carries oxygen, and the study will compare two strategies for blood transfusions: one that keeps hemoglobin levels at the current recommended level and another that aims to raise hemoglobin closer to normal levels. The hope is that maintaining higher hemoglobin levels could help reduce the risk of bleeding for these patients.
To participate in this study, you need to be at least 18 years old and currently hospitalized with a diagnosis of AML or acute lymphocytic leukemia, having started chemotherapy treatment within the last five days and having a hemoglobin level below 130 g/L. If you join the trial, you will receive blood transfusions as part of your treatment based on the study's strategies. This pilot study is a first step to see if a larger trial can be done in the future, so it’s a valuable opportunity for both patients and researchers to gather important information.
Gender
ALL
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%) .
About Donald Arnold
Donald Arnold is a distinguished clinical trial sponsor known for his commitment to advancing medical research and innovation. With a robust background in clinical development and regulatory affairs, he leads initiatives that focus on evaluating novel therapeutic interventions across various therapeutic areas. His collaborative approach fosters strong partnerships with research institutions and healthcare professionals, ensuring the highest standards of ethical conduct and scientific rigor are upheld throughout the trial process. Under his guidance, the organization is dedicated to enhancing patient outcomes and contributing to the broader healthcare community through responsible and impactful clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hamilton, Ontario, Canada
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported