Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 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:
- To assess the incidence and type of coagulation disorders during the perioperative period of these two types of transplantation
- 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
- 否
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
研究组 & 干预措施
Arm kidney transplanted
Arm kidney transplanted: all patients who receive kidney transplantation
干预措施: Blood sample (Biological)
Arm pancreas-kidney transplanted
Arm pancreas-kidney transplanted: all patients who receive pancreas-kidney transplantation
干预措施: Blood sample (Biological)
结局指标
主要结局
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
时间窗: 48 hours
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
时间窗: 24 hours
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
时间窗: preoperative period
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
时间窗: 45 min after transplant unclamp
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
时间窗: Intensice Care Unit admission
次要结局
- standard coagulation parameters(48 hours)
- standard coagulation parameters(Intensice Care Unit admission)
- standard coagulation parameters(24 hours)
- standard coagulation parameters(preoperative period)
- standard coagulation parameters(45 min after transplant unclamp)
