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临床试验/NCT00769873
NCT00769873终止2 期

Effect of Anticoagulation in Reducing the Incidence of Splenic/Portal Vein Thrombosis Post-Laparoscopic Splenectomy Protocol Number: 5698

University of Alberta2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2006年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
35
试验地点
2
主要终点
The incidence of portal/splenic vein thrombosis post laparoscopic splenectomy

研究概览

简要总结

Splenic/portal vein thrombosis is an alarming complication of splenectomy. Retrospective studies in the literature have shown the incidence of symptomatic splenic/portal vein thrombosis to be between 0.7% (Rattner et al., 1993) to 8% (Winslow et al., 2002). This is a single-center, prospective, randomized study in subjects undergoing laparoscopic splenectomy. All participants will receive one dose of pre-operative low molecular weight heparin (Lovenox®) subcutaneously, 2 hours prior to surgery. Participants will be randomized pre-operatively to treatment or control group however the treatment allocation will not be revealed until the surgery is complete. Postoperatively, those assigned to the treatment group will receive 40 mg of Lovenox® subcutaneously once a day for 21 days; those in the control group will not. Patients with severe renal impairment will receive an adjusted dose of Lovenox® (30 mg subcutaneous dose daily). All patients will have a baseline abdominal Doppler ultrasound preoperatively and a second one done at 14 to 28 days post surgery to monitor for the presence of portal vein and/or splenic vein thrombosis. They will also have their lipase and liver function tests checked to correlate with the imaging findings.

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
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

入选标准

  • Scheduled to undergo laparoscopic splenectomy at The University of Alberta or Grey Nun's Community Hospitals
  • Capable of understanding the purpose and risks of the study and willing/able to sign a statement of informed consent
  • Willing to undergo daily subcutaneous injections of Lovenox®

排除标准

  • Pregnant or nursing
  • Unable or unwilling to provide informed consent
  • Bleeding diathesis or currently on anticoagulation therapy (i.e. coumadin, heparin, LMWH)
  • Hemorrhagic cerebral vascular accident
  • Severe uncontrolled hypertension
  • Diabetic or hemorrhagic retinopathy
  • Contradictions to anticoagulation (i.e. active GI bleed, gastric or duodenal ulcer, sustained platelet count < 50 x103/uL, splenectomy due to trauma or history of heparin induced thrombocytopenia)
  • Conversion to open splenectomy
  • Allergy to Lovenox®, heparin, or other low molecular weight heparins
  • Bacterial endocarditis

研究组 & 干预措施

Lovenox

Active Comparator

Patients receive Lovenox 40mg SC daily (30mg SC daily if creatinine clearance < 30) for 21 days after laparoscopic splenectomy

干预措施: Enoxaparin (Drug)

结局指标

主要结局

The incidence of portal/splenic vein thrombosis post laparoscopic splenectomy

时间窗: three years

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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