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临床试验/NCT01626911
NCT01626911Unknown不适用

Continuous Regional Arterial Infusion of Low Molecular Weight Heparin in Patients With Severe Acute Pancreatitis

Nanjing University School of Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
coagulation related complications

研究概览

简要总结

Our animal studies found that continuous regional arterial infusion (CRAI in the celiac trunk) of low molecular weight heparin (LMWH) could alleviate inflammation, improve global hemodynamics and restore organ function in a porcine model of severe acute pancreatitis (SAP,unpublished).

In this study, the investigators aim to evaluate the effects of CRAI of LMWH in the treatment of SAP patients. The investigators suppose CRAI could help improve the outcomes of these patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptoms and signs of severe acute pancreatitis according to Atlanta criteria
  • Within 3 days from the onset of the disease
  • Available for interventional treatment(not sensible to radiocontrast agent)

排除标准

  • Pregnant pancreatitis
  • Receiving surgery or aspiration before;need of early surgery
  • Patients with coagulation disorders

结局指标

主要结局

coagulation related complications

时间窗: 14 days after the placement of celiac trunk catheter

bleeding for the most coagulative parameters

Pancreatic infection

时间窗: 28 days

次要结局

  • Hospital duration(Participants will be followed until the date of discharge from the hospital,assessed up to 3 months. Patients who die during hospitalization are excluded from this measurement.)
  • Mortality(Participants will be followed until the date of discharge or the date of death from any cause, whichever came first, assessed up to 3 months)
  • pancreatic necrosis(28 days)
  • ICU duration(Participants will be followed until the date of discharge from the ICU,assessed up to 6 weeks. Patients who die during hospitalization are excluded from this measurement.)

研究者

发起方
Nanjing University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Weiqin Li

Director of surgical ICU

Nanjing University School of Medicine

研究点 (1)

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