NCT00135876已完成3 期
A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE)
Ontario Clinical Oncology Group (OCOG)28 个研究点 分布在 4 个国家目标入组 512 人开始时间: 2002年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 512
- 试验地点
- 28
- 主要终点
- objectively-proven symptomatic VTE (DVT or PE)
研究概览
简要总结
In patients with malignant glioma, to determine the efficacy of prophylaxis with LMWH (dalteparin) compared to placebo, both commenced beyond the immediate postoperative period, for the prevention of VTE.
详细描述
Patients are randomized 1:1 to receive dalteparin 5,000 anti-Xa units s.c. daily versus placebo s.c. daily. The primary outcome is VTE-free survival at 6 months. Progression free survival; overall survival, toxicity, and neurocognitive performance are secondary outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
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
- •Both of the following criteria must be satisfied:
- •Patients with newly-diagnosed pathologically-confirmed WHO Grade 3 or Grade 4 glioma (anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, anaplastic oligodendroglioma, and anaplastic mixed glioma). Tumour histology is based on local pathology review only;
- •Patients 18 years of age or older at time of randomization
排除标准
- •If one or more of the following criteria are satisfied, the patient is not eligible for the study:
- •The presence of acute or chronic DVT demonstrated by duplex ultrasonography (DUS) or venography. (Note: a screening DUS is not required for study entry);
- •Inability to commence study drug within four weeks of original surgery or biopsy;
- •Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within four weeks of potential study entry;
- •Presence of a coagulopathy (e.g. INR >1.5 or platelet count < 100x109/L);
- •Symptomatic intracranial or intratumoural bleeding. (Note: post-operative imaging of the brain is not required for study entry. Asymptomatic "routine" post-operative blood products in a post-surgical cavity are not an exclusion;
- •Known acute (symptomatic or actively bleeding) gastroduodenal ulcer;
- •Familial bleeding diathesis;
- •Requiring long term anticoagulants for other reasons (e.g., mechanical heart valves, atrial fibrillation);
- •Uncontrolled hypertension despite antihypertensive therapy;
- •Significant renal failure (dependent on dialysis or creatinine of greater than three times upper limit of normal control);
- •Prior history of documented DVT or PE;
- •Allergy to anticoagulants (UFH, LMWH) including immune-mediated heparin-induced thrombocytopenia;
- •Pregnant or of childbearing potential and not using adequate contraception;
- •Geographically inaccessible for follow-up;
- •Having an expected life span of less than 6 months;
- •Body weight < 40 kg.
结局指标
主要结局
objectively-proven symptomatic VTE (DVT or PE)
次要结局
- bleeding (major and all bleeding)
- quality of life
- cognition assessments
- death
研究者
研究点 (28)
Loading locations...
相似试验
终止
不适用
LMWH to Prevent Preeclampsia and Fetal Growth RestrictionPreeclampsiaNCT00260520University of Florence
已完成
3 期
PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)Critical IllnessDeep Venous ThrombosisNCT00182143McMaster University3,659
已完成
不适用
Evaluation of the Effectiveness of Prophylactic LMWH by ThromboelastographyMalignancyNCT06484231Ege University25
已完成
不适用
Pharmacokinetics of Dalteparin in Patients With Impaired Renal FunctionRenal InsufficiencyNCT00264693Luzerner Kantonsspital96
已完成
4 期
The Use of Low Molecular Weight Heparin in Traumatic Brain InjuryVenous ThrombosisBrain InjuryNCT00170378Hennepin Healthcare Research Institute300