Thromboelastography and Pancreas-kidney Transplantation (TEG-PKT)

Civil Hospices of Lyon

Status: Completed

Conditions: Blood Coagulation

Treatments: Biological: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT02385006

2012.727

Details and patient eligibility

About

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)

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 2 patient groups

Arm kidney transplanted

Other group

Description:

Arm kidney transplanted: all patients who receive kidney transplantation

Treatment:

Biological: Blood sample

Arm pancreas-kidney transplanted

Other group

Description:

Arm pancreas-kidney transplanted: all patients who receive pancreas-kidney transplantation

Treatment:

Biological: Blood sample