Clinical trial · Interventional
Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding
Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding (BAIT): A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Acute Lymphocytic Leukaemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RBC transfusion strategy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/LL
- description
- 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.
- interventionNames
- Procedure: RBC transfusion strategy
- type
- NO_INTERVENTION
- label
- Standard-of-care RBC transfusion strategy
- description
- 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.
Primary outcomes (5)
- measure
- Effect of maintaining a higher hemoglobin level (110 g/L) compared with the standard hemoglobin level on bleeding-related biomarkers.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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%) .
References
Publications (0)
Data not yet available