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Thromboelastography and Pancreas-kidney Transplantation

NCT02385006 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2015-03-11

No results posted yet for this study

Summary

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)

Conditions

  • Blood Coagulation

Interventions

BIOLOGICAL

Blood sample

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02385006 on ClinicalTrials.gov