NCT02385006

Thromboelastography and Pancreas-kidney Transplantation

Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Blood Coagulation

Interventions

Type	Name	Description
BIOLOGICAL	Blood sample

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2015-03-11
• Last updated: 2015-03-11

Locations

1 site across 1 country: France