Ignite Creation Date:
2024-05-06 @ 3:50 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02385006
Status:
COMPLETED
Last Update Posted:
2015-03-11
First Post:
2015-02-26
Brief Title:
Thromboelastography and Pancreas-kidney Transplantation
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEG-PKT
Brief Summary:
Type of studyProspective 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 2012727
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 2012727
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None