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临床试验/NCT02385006
NCT02385006已完成不适用

Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
152
试验地点
2
主要终点
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring

研究概览

简要总结

Type of study:Prospective, single-center, non-therapeutic, of routine care No randomization, no modifications of the usual care, study results are not available for the physicians in charge of the patient.

Objectives:

  • The main objective of this study is to evaluate the ability of the thromboelastogram (ROTEM®) to detect clotting disorders related to pancreas-kidney transplantation, comparing ROTEM ® profiles during the perioperative period of two different types of transplantation (kidney alone and simultaneous pancreas-kidney)
  • The secondary objectives are:
  1. To assess the incidence and type of coagulation disorders during the perioperative period of these two types of transplantation
  2. To study correlation values between thrombolelastogram and standard coagulation parameters

Population study:

  • Evaluated group: 40 pancreas-kidney recipients
  • Control group: 80 kidney recipients
  • Recruitment periods: 24 months
  • Patient Monitoring: 48 hours
  • Total duration of the study: 36 months.
  • Ethics: Study of routine care. Oral and written information given to patients. Validation of the study protocol by the local ethics committee (CPP Sud Est II: Protocol No. HCL / P 2012.727)

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Care Provider)

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

  • Men, women > 18 years old
  • Kidney or pancreas-kidney recipients
  • Not opposed to research
  • With no legal protection
  • Affiliated to social security system

排除标准

  • Enrollment in an other research protocol, incompatible with the trial according to the investigator

结局指标

主要结局

Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring

时间窗: 48 hours

次要结局

  • standard coagulation parameters(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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