Thromboelastography and Pancreas-kidney Transplantation
NCT ID: NCT02385006
Last Updated: 2015-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
152 participants
INTERVENTIONAL
2013-02-28
2014-11-30
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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Arm kidney transplanted
Arm kidney transplanted: all patients who receive kidney transplantation
Blood sample
Arm pancreas-kidney transplanted
Arm pancreas-kidney transplanted: all patients who receive pancreas-kidney transplantation
Blood sample
Interventions
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Blood sample
Eligibility Criteria
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Inclusion Criteria
* Kidney or pancreas-kidney recipients
* Not opposed to research
* With no legal protection
* Affiliated to social security system
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Anesthesiology and Critical Care Medicine, Edouard Herriot Hospital, Hospices Civils de Lyon
Lyon, , France
Countries
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Other Identifiers
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2012.727
Identifier Type: -
Identifier Source: org_study_id
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