Skip to main content
OpenTrials
Completed

NCT Number: NCT02385006

Thromboelastography and 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)

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

Primary outcomes

  1. Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring

    Time frame: preoperative period

  2. Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring

    Time frame: 45 min after transplant unclamp

  3. Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring

    Time frame: Intensice Care Unit admission

  4. Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring

    Time frame: 24 hours

  5. Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring

    Time frame: 48 hours

Secondary outcomes

  1. standard coagulation parameters

    Time frame: preoperative period

  2. standard coagulation parameters

    Time frame: 45 min after transplant unclamp

  3. standard coagulation parameters

    Time frame: Intensice Care Unit admission

  4. standard coagulation parameters

    Time frame: 24 hours

  5. standard coagulation parameters

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation

Acronym: TEG-PKT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2015
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.