Thromboelastography and Pancreas-kidney Transplantation (TEG-PKT)

March 4, 2015 updated by: Hospices Civils de Lyon

Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Anesthesiology and Critical Care Medicine, Edouard Herriot Hospital, Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012.727

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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