Management of Venous Thromboembolic Events (VTE) in Patients With Hematologic Disorders and Treatment-Induced Thrombocytopenia: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of Patients Consenting to Enrollment
研究概览
简要总结
This pilot clinical trial compares the safety of two different platelet transfusion "thresholds" among patients with blood cancer or treatment-induced thrombocytopenia whose condition requires anticoagulant medication (blood thinners) for blood clots. Giving relatively fewer platelet transfusions may reduce the side effects of frequent platelet transfusions without leading to undue bleeding.
详细描述
PRIMARY OBJECTIVES:
I. To determine feasibility of a randomized controlled trial comparing two different platelet transfusion thresholds (50 x 10^9/L versus [vs] 30 x 10^9/L) in patients with treatment or malignancy-induced thrombocytopenia requiring therapeutic anticoagulation.
SECONDARY OBJECTIVES:
I. Progressive or new venous thromboembolic (VTE).
II. Progressive or new arterial thromboembolism (ATE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Any patient with non-acute promyelocytic leukemia (APL) acute leukemia (acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL], biphenotypic leukemia) undergoing curative intent chemotherapy OR any patient undergoing allogeneic hematopoietic stem cell transplantation (HSCT) for a hematologic disorder (including acute leukemia as above, chronic myelogenous leukemia [CML], chronic lymphocytic leukemia [CLL], myelodysplastic syndrome [MDS], primary or secondary myelofibrosis, hypereosinophilic syndromes, plasma cell disorders, B-cell or T-cell lymphoma)
- •Disease may be measurable or non-measurable
- •Diagnosis of symptomatic venous thromboembolism requiring therapeutic-dose anticoagulation (unfractionated or low-molecular weight heparin or oral anticoagulants) throughout the period of hematopoietic recovery
- •Anticipated platelet count =< 50 x 10^9/L for >= 5 days within 72 hours of enrollment
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Separate episode of VTE or arterial thrombosis within 3 months of enrollment
- •Major bleed (WHO grade 3 or 4) within 6 months of enrollment
- •Active bleeding (grade 2 or higher) at the time of enrollment
- •History of intracranial bleeding at any time
- •Disorders of hemostasis including von Willebrand disease, hemophilia, platelet function disorders
- •Concomitant use of aspirin or non-steroidal anti-inflammatory drugs
- •Evidence of disseminated intravascular anticoagulation (DIC) as determined by the patient's primary provider
- •History of alloimmunization (defined as platelet refractoriness with panel reactive antibody [PRA] > 25%) at the time of or prior to enrollment
- •Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant or able to become pregnant and unwilling to use two forms of birth control during the study period
研究组 & 干预措施
Group I (lower dose platelet transfusion)
Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions.
干预措施: Platelet Transfusion (Biological)
Group II (higher dose platelet transfusion)
Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions.
干预措施: Platelet Transfusion (Biological)
结局指标
主要结局
Number of Patients Consenting to Enrollment
时间窗: Up to 1 year
Number of Eligible Patients Approached for the Study
时间窗: Up to 1 year
Number of Patients Approached for But Refusing Consent
时间窗: Up to 1 year
Reasons for ineligibility will be reported qualitatively in order to inform future studies.
Number of Patients Eligible
时间窗: Up to 1 year
Number of Patients Successfully Following Protocol
时间窗: Up to 1 year
Will evaluate the number of patients successfully following protocol, defined as receiving transfusions 'on protocol' at the end of the study period.
Number of Patients Screened and Deemed Ineligible
时间窗: Up to 1 year
Reasons for ineligibility will be reported qualitatively in order to inform future studies.
次要结局
- Number of Platelet Transfusions Per Patient During the Study Period(Up to 1 year)
- Platelet Transfusion Related Complications(Up to 1 year)
- Percent of Days on Which Subjects Are Transfused (or Transfusion Are Not Given)(Up to 1 year)
- Progressive or New Arterial Thromboembolism(Up to 1 year)
- Progressive or New Venous Thromboembolic(Up to 1 year)
- Incidence of Hemorrhagic Events (World Health Organization Grade 2 or Greater)(Up to 1 year)
- Major Bleeds (World Health Organization Grade 3 or 4)(Up to 1 year)