JPRN-jRCT1051190020已完成2 期
Safety and efficacy of postoperative enoxaparin treatment in patients undergoing curative hepatobiliary-pancreatic cancer surgery: a prospective, Phase Two, multi-center study - CSGO-HBP-013
Kobayashi Syogo0 个研究点目标入组 262 人开始时间: 2019年5月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 262
研究概览
简要总结
After surgery for hepatobiliary-pancreatic cancer, the rate of venous thromboembolism in enoxaparin group was 1.7% compared with that in control group (3.4%). In this study, subcutaneous administration of enoxaparin after surgery did not prevent the onset of venous thromboembolism.It may be considered as one of the preventive measures in the future.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 40age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1,Hepatobiliary-pancreatic cancer with surgical resection.(excluded foe pancreatoduodenectomy or hepatic resection with biliary reconstruction)
- •2,Aged 40 over years old.
- •3,Expected for survival of more than 6 months after surgery.
- •4,Child-Pugh A
- •5,Informed Consent
排除标准
- •1 Symptom of deep venous thrombus.
- •2 Treatment of estrogen or progesterone within 4 weeks before administration.
- •3 Chemotherapy or radiotherapy within 2 weeks before administration.
- •4 Receiving anticoagulant (heparin or warfarin), anti-platelet therapy,
- •aspirin from 2 days before the operation
- •5 Severe renal dysfunction (less than 30 mL/min of creatinine clearance)
- •6 Platelet count < 75000/mm^2,
- •7 APTT > 50
- •8 History of thrombocytopenia caused by heparin.
- •9 History of surgery for eye, spinal or central nerve system within 2 weeks.
- •10 History of peptic ulcer or bleeding within 3 months
- •11 History of cerebral hemorrhage within 1 year
- •12 History of allergy for heparin or biological products.
- •13 Patients with acute bacterial endocarditis
- •14 Pregnancy
- •15 others, in the investigator's judgment
研究者
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