Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding (BAIT): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Consent rate (feasibility outcome)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old.
- •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.
排除标准
- •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%) .
研究组 & 干预措施
RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/LL
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.
干预措施: RBC transfusion strategy (Procedure)
Standard-of-care RBC transfusion strategy
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.
结局指标
主要结局
Consent rate (feasibility outcome)
时间窗: Through study completion, an average of 1.5 years
The proportion of potential participants who agree to participate in the study.
Effect of maintaining a higher hemoglobin level (110 g/L) compared with the standard hemoglobin level on bleeding-related biomarkers.
时间窗: Samples will be collected before chemotherapy onset, and on days 7, 14, and 28. The first day of chemotherapy is considered day 1
Blood and urine samples will be taken from participants at selected timepoints to measure levels of biomarkers from the endothelial integrity, inflammation, and fibrinolysis/coagulation domains.
Protocol adherence to the study intervention (feasibility outcome)
时间窗: Day 1 to 30
The total number of days where hemoglobin levels were above the assigned threshold or days where RBCs were administered when the hemoglobin level was reported to be below that threshold.
Protocol adherence to the study schedule (feasibility outcome)
时间窗: Day 1 to 30
Measurement of how consistently participants and study staff follow the prescribed schedule for study assessments and sample collections as outlined in the study protocol. Measurements include percentage of scheduled biomarker testing days with data collected, percentage of non-weekday study days with completed bleeding assessments, and percentage of scheduled study days with completed FACT questionnaires.
Screen failure rate (feasibility outcome)
时间窗: Through study completion, an average of 1.5 years
The proportion of participants who are screened for eligibility but do not meet the study's inclusion and exclusion criteria and are therefore not enrolled in the trial.
次要结局
- The association between the hemoglobin threshold used and bleeding events(Day 1 to 30)
- The total number of blood products administered to participants in the liberal and standard arms of the study(Day 1 to 30)
- The association between the hemoglobin threshold used and quality-of-life(Assessed weekly, from before chemotherapy onset to day 28)
研究者
Donald Arnold
Principal Investigator
McMaster University