A Randomized, Phase II Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total Number of Venous Thromboembolic Events (VTE) in Standard Dose Enoxaparin Arm at 17 Days
研究概览
简要总结
Hospitalized patients with histologically or cytologically confirmed diagnosis of solid tumor malignancy, lymphoma, or multiple myeloma and who are at high risk for a venous thromboembolism will be randomized to standard dose versus intermediate dose enoxaparin.
详细描述
In a phase II trial, high risk hospitalized cancer patients will be enrolled and randomized to standard dose enoxaparin versus intermediate dose (weight adjusted) enoxaparin thromboprophylaxis. Study subjects will be administered enoxaparin during hospitalization in a double-blinded manner. Following completion of 14 days, the study arms will be unblinded and lower extremity ultrasound performed on the standard dose enoxaparin arm in order to more accurately determine the overall cumulative incidence of thrombosis in this group.
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
- Double (Participant, Investigator)
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
- •Participants must have histologically or cytologically confirmed diagnosis of solid tumor malignancy, lymphoma or multiple myeloma.
- •Cancer diagnosis or received treatment (chemotherapy or radiotherapy) for malignancy within the previous 6 months
- •One or more Padua-based risk factor:
- •History of previous venous thromboembolic event (excluding superficial vein thrombosis)
- •Reduced mobility (ECOG performance status 3 or 4, see Appendix A)
- •Established hereditary thrombophilia (e.g. Factor V Leiden, G20210 prothrombin mutation, protein C or S deficiency, antithrombin deficiency).
- •Recent surgery within the last 30 days
- •Age ≥ 70 years
- •Congestive heart failure (NYHA class III or IV)
- •Complicated respiratory insufficiency (defined as an increased requirement for supplementary oxygen of at least 2L)
- •Acute myocardial infarction or ischemic stroke
- •Obesity (BMI ≥ 30)
- •Receiving hormonal agents (e.g. tamoxifen, estrogen, testosterone)
- •Acute infection (i.e. requiring antimicrobial therapy)
- •Age ≥ 18 years
- •Life expectancy of greater than 30 days
- •Platelet count ≥ 100,000/mcL
- •Creatinine < 1.5 mg/dL or estimated creatinine clearance ≥ 50 mL/min/1.73 m2
- •Ability to understand and the willingness to sign a written informed consent document
- •Weight between 50kg to 130 kg.
排除标准
- •History of allergic reactions attributed to heparin or low molecular weight heparin
- •Active bleeding or otherwise considered high risk for hemorrhage (e.g. known acute gastrointestinal ulcer)
- •Any history of significant hemorrhage (requiring hospitalization or transfusion) within the last 6 months (excluding hemorrhage during operative procedure).
- •History of heparin induced Thrombocytopenia
- •Presence of coagulopathy (PT or PTT> 1.2 x upper limit of normal)
- •Known diagnosis of disseminated intravascular coagulation
- •Currently receiving therapeutic anticoagulant therapy or dual antiplatelet therapy (eg. aspirin and clopidogrel)
- •Uncontrolled arterial hypertension (systolic blood pressure > 200mmHg, diastolic >110mmHg)
- •Active peptic ulcer disease
- •Bacterial Endocardititis
- •Received any type of Pharmacologic Thromboprophylaxis (e.g. low molecular weight heparin or heparin) for >48 hours during current hospitalization
- •Known brain metastases
研究组 & 干预措施
A: Standard Dose Enoxaparin
Participants will receive Enoxaparin 40 mg subcutaneously once daily. On study Enoxaparin will be administered for up 14 days during hospitalization.
After the day 14 assessment, treatment arms will be un-blinded in order to appropriately schedule a bilateral lower extremity ultrasound for participants enrolled onto Arm A at day 17.
干预措施: Enoxaparin (Drug)
B: Weight Adjusted Enoxaparin
Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily. Participants who weigh more than 100kg will be capped at 100mg.
On study Enoxaparin will be administered for up 14 days during hospitalization.
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Total Number of Venous Thromboembolic Events (VTE) in Standard Dose Enoxaparin Arm at 17 Days
时间窗: 17 days only measured in Arm A (Standard dose enoxaparin)
To investigate the numbers of VTE in hospitalized cancer patients receiving standard dose
Number Participants With Major Hemorrhage
时间窗: 14 days
Number of major hemorrhage in weight-adjusted enoxaparin arm and standard-dose enoxaparin arm
次要结局
- Number of Symptomatic Venous Thromboembolic Events (VTE)(14 days)
研究者
Jeffrey Zwicker, MD
Jeffrey Zwicker, MD
Dana-Farber Cancer Institute