Thromboelastography and Pancreas-kidney Transplantation

Not Applicable

Completed

• Conditions: Blood Coagulation
• Interventions: Biological: Blood sample

• Registration Number: NCT02385006
• Lead Sponsor: Hospices Civils de Lyon

Brief 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)

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-03
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-04
• Last Update Submitted: 2015-03-04
• Study First Posted: 2015-03-11
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm pancreas-kidney transplanted	Blood sample	Arm pancreas-kidney transplanted: all patients who receive pancreas-kidney transplantation
Arm kidney transplanted	Blood sample	Arm kidney transplanted: all patients who receive kidney transplantation

Primary Outcome Measures

Name	Time	Method
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring	48 hours

Secondary Outcome Measures

Name	Time	Method
standard coagulation parameters	48 hours

Trial Locations

Locations (1)

Anesthesiology and Critical Care Medicine, Edouard Herriot Hospital, Hospices Civils de Lyon; 🇫🇷 Lyon, France