Thromboelastography and Pancreas-kidney Transplantation — TEG-PKT  

Blood Coagulation Clinical Trial

Official title: Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation

Status Completed

Clinical Trial 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)

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Screening

Related Conditions & MeSH terms

• Blood Coagulation

• NCT number: NCT02385006
• Study type: Interventional
• Source: Hospices Civils de Lyon
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Completion date: November 2014