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Thromboelastography and Pancreas-kidney Transplantation

Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02385006
Acronym
TEG-PKT
Enrollment
152
Registered
2015-03-11
Start date
2013-02-28
Completion date
2014-11-30
Last updated
2015-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Coagulation

Keywords

Thromboelastography, simulatneous pancreas-kidney transplantation

Brief 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)

Interventions

BIOLOGICALBlood sample

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoringpreoperative period

Secondary

MeasureTime frame
standard coagulation parameterspreoperative period

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026