Clinical trial NCT02385006: Thromboelastography and Pancreas-kidney Transplantation
Official title: Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Coagulation
Keywords: Thromboelastography
simulatneous pancreas-kidney transplantation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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)


Eligibility criteria: 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

Primary outcomes:
measure: Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
timeFrame: preoperative period
measure: Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
timeFrame: 45 min after transplant unclamp
measure: Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
timeFrame: Intensice Care Unit admission
measure: Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
timeFrame: 24 hours
measure: Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
timeFrame: 48 hours
Secondary outcomes:
measure: standard coagulation parameters
timeFrame: preoperative period
measure: standard coagulation parameters
timeFrame: 45 min after transplant unclamp
measure: standard coagulation parameters
timeFrame: Intensice Care Unit admission
measure: standard coagulation parameters
timeFrame: 24 hours
measure: standard coagulation parameters
timeFrame: 48 hours
Other outcomes:
Locations:
city: Lyon
country: France
facility: Anesthesiology and Critical Care Medicine, Edouard Herriot Hospital, Hospices Civils de Lyon
Study officials:
References: