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Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients

2021年7月6日 更新者:Jeffrey Zwicker, MD、Dana-Farber Cancer Institute

A Randomized, Phase II Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients

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.

研究概览

地位

完全的

详细说明

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.

研究类型

介入性

注册 (实际的)

50

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Beth Israel Deaconess Medical Center
    • Ohio
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic Foundation

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器: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.

其他名称:
  • 洛维诺克斯
有源比较器: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.

其他名称:
  • 洛维诺克斯

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Total Number of Venous Thromboembolic Events (VTE) in Standard Dose Enoxaparin Arm at 17 Days
大体时间:17 days only measured in Arm A (Standard dose enoxaparin)
To investigate the numbers of VTE in hospitalized cancer patients receiving standard dose
17 days only measured in Arm A (Standard dose enoxaparin)
Number Participants With Major Hemorrhage
大体时间:14 days
Number of major hemorrhage in weight-adjusted enoxaparin arm and standard-dose enoxaparin arm
14 days

次要结果测量

结果测量
措施说明
大体时间
Number of Symptomatic Venous Thromboembolic Events (VTE)
大体时间:14 days
Comparing number of symptomatic VTE (data collected prior to unblinding) for the standard dose (Arm A) versus intermediate dose enoxaparin (Arm B).
14 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jeffrey Zwicker, MD、Beth Israel Deaconess Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年4月1日

初级完成 (实际的)

2020年12月7日

研究完成 (实际的)

2021年6月7日

研究注册日期

首次提交

2016年3月3日

首先提交符合 QC 标准的

2016年3月7日

首次发布 (估计)

2016年3月11日

研究记录更新

最后更新发布 (实际的)

2021年7月8日

上次提交的符合 QC 标准的更新

2021年7月6日

最后验证

2021年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 15-547

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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