Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding

Официальное название

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

Обзор

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.

Вмешательства

• Процедура RBC transfusion strategy
  RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/L.

Первичные конечные точки

• Effect of maintaining a higher hemoglobin level (110 g/L) compared with the standard hemoglobin level on bleeding-related biomarkers. [Срок оценки: Samples will be collected before chemotherapy onset, and on days 7, 14, and 28. The first day of chemotherapy is considered day 1]
• Protocol adherence to the study intervention (feasibility outcome) [Срок оценки: Day 1 to 30]
• Protocol adherence to the study schedule (feasibility outcome) [Срок оценки: Day 1 to 30]
• Consent rate (feasibility outcome) [Срок оценки: Through study completion, an average of 1.5 years]
• Screen failure rate (feasibility outcome) [Срок оценки: Through study completion, an average of 1.5 years]

Вторичные конечные точки (3)

• The total number of blood products administered to participants in the liberal and standard arms of the study [Срок оценки: Day 1 to 30]
• The association between the hemoglobin threshold used and bleeding events [Срок оценки: Day 1 to 30]
• The association between the hemoglobin threshold used and quality-of-life [Срок оценки: Assessed weekly, from before chemotherapy onset to day 28]

Критерии участия

Критерии включения

• ≥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.

Критерии исключения

• Failure to provide informed consent.
• Unwilling to receive blood transfusions.
• Life expectancy <72 hours.
• Undergoing palliative chemotherapy.
• Requires specialized blood products (e.g., antigen-matched, irradiation, etc.).
• Diagnosis of acute promyelocytic leukemia.
• 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)
• Evidence of iron overload (ferritin >800 ng/mL, transferrin saturation >80%) .

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Juravinski Hospital — Hamilton

Идентификаторы

NCT: NCT06947044 · 15529

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗