Randomized Clinical Trial of Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients Undergoing Chemotherapy Treatment.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Number of Participants With Venous Thromboembolic Events (VTE)
研究概览
简要总结
The goal of this clinical research study is to learn if dalteparin can lower the risk of VTE occurring in the legs and lungs. This will be tested in patients with pancreatic cancer who are going to receive chemotherapy. Some patients will receive dalteparin and some will receive no study drug.
The safety of dalteparin will also be studied.
详细描述
Study Drug:
Dalteparin is designed to thin the blood and block blood from clotting. This may lower the risk of VTE.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) into 1 of 2 groups. There is an equal chance of being assigned to either group.
Group 1 will receive dalteparin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Patients with the diagnosis of advanced stage (unresectable or metastatic) adenocarinoma of the pancreas. Patients with borderline resectable will also be eligible if they are starting chemotherapy and/or chemo/radiation therapy (RT) prior to attempting resection.
- •Patients must be planning to initiate systemic chemotherapy within 2 weeks. Chemotherapy that is being given concurrently with radiation is allowed.
- •Age >/= 18 years old
- •Adequate renal function defined as a calculated creatinine clearance of > 50 mL/min (as reported by the MDACC laboratory using MDRD method or using Cockroft and Gault formula).
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-
- •Negative urine or serum pregnancy test in women with childbearing potential, within one week prior to initiation of treatment.
- •Patients must sign an Informed Consent.
- •Patient must agree to transfusion of blood products, when indicated.
- •Ability to administer subcutaneous injections of the study drug by the patient and/or care giver.
排除标准
- •Patients with evidence of venous thrombosis on the initial lower extremity screening ultrasound or incidental VTE of other sites (e.g. PE, Abdominal/pelvic vein thrombosis, etc.).
- •Patients already taking prophylactic or full dose anticoagulation (eg. heparin, low-molecular weight heparin, fondaparinux, or coumadin).
- •Patients with currently active bleeding.
- •The presence of a condition with a high risk for bleeding, including but not limited to active peptic ulcer, recent neurosurgery, or cirrhosis with esophageal varices.
- •Patients with known brain metastases.
- •Patients with a known bleeding diathesis.
- •Patients with a platelet count < 50,
- •Patients with known hypersensitivity to dalteparin.
- •Patients who regularly use medications known to increase the risk of bleeding such as >/= 325 mg of aspirin daily, or daily clopidogrel, or daily non-steroidal antiinflammatory medications (eg., ibuprofen, naproxen).
研究组 & 干预措施
Group 1: Dalteparin
Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
干预措施: Dalteparin (Drug)
结局指标
主要结局
Number of Participants With Venous Thromboembolic Events (VTE)
时间窗: 16 weeks of treatment
Venous thromboembolism (VTE) defined by both symptomatic and asymptomatic VTE which includes deep venous thrombosis (DVT) and pulmonary embolism (PE) through clinical assessments and radiologic studies. All patients undergo bilateral lower extremity ultrasound every 2 months while on study (total of 3 exams including pre-randomization). VTE requires imaging documentation to evaluate use of prophylactic anticoagulation in reducing the occurrence of VTE in a patient population with a known high risk of VTE.
次要结局
未报告次要终点