NCT06947044

Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Donald Arnold · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Leukemia
• Acute Myeloid Leukemia (AML)
• Acute Lymphocytic Leukaemia

Interventions

Type	Name	Description
PROCEDURE	RBC transfusion strategy	RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/L.

Timeline

• Start date: 2025-04-11
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-04-27
• Last updated: 2025-04-27

Locations

1 site across 1 country: Canada