Thromboelastography and Pancreas-kidney Transplantation

Study Overview
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Brief Summary
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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)

Official Title
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Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation

Conditions
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Blood Coagulation

Intervention / Treatment
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* Biological: Blood sample


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: -Enrollment in an other research protocol, incompatible with the trial according to the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm kidney transplanted<br>Arm kidney transplanted: all patients who receive kidney transplantation | Biological: Blood sample<br> <br> |
| Other: Arm pancreas-kidney transplanted<br>Arm pancreas-kidney transplanted: all patients who receive pancreas-kidney transplantation | Biological: Blood sample<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring |  | preoperative period | 
| Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring |  | 45 min after transplant unclamp | 
| Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring |  | Intensice Care Unit admission | 
| Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring |  | 24 hours | 
| Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| standard coagulation parameters |  | preoperative period | 
| standard coagulation parameters |  | 45 min after transplant unclamp | 
| standard coagulation parameters |  | Intensice Care Unit admission | 
| standard coagulation parameters |  | 24 hours | 
| standard coagulation parameters |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thromboelastography, simulatneous pancreas-kidney transplantation