Thromboelastography and Pancreas-kidney Transplantation

Overview

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)

Full Title of Study: “Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: November 2014

Interventions

  • Biological: Blood sample

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • standard coagulation parameters
    • Time Frame: preoperative period
  • standard coagulation parameters
    • Time Frame: 45 min after transplant unclamp
  • standard coagulation parameters
    • Time Frame: Intensice Care Unit admission
  • standard coagulation parameters
    • Time Frame: 24 hours
  • standard coagulation parameters
    • Time Frame: 48 hours

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor

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