Thromboelastography and Pancreas-kidney Transplantation

Blood Coagulation Clinical Trial

— TEG-PKT  

Official title:

Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385006
• Other study ID #: 2012.727
• Status: Completed
• Phase: N/A
• First received: February 26, 2015
• Last updated: March 4, 2015
• Start date: February 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2013
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Screening

Related Conditions & MeSH terms

• Blood Coagulation

Intervention

Biological:
• Blood sample

Locations

Country	Name	City	State
France	Anesthesiology and Critical Care Medicine, Edouard Herriot Hospital, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring		preoperative period	No
Primary	Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring		45 min after transplant unclamp	No
Primary	Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring		Intensice Care Unit admission	No
Primary	Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring		24 hours	No
Primary	Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring		48 hours	No
Secondary	standard coagulation parameters		preoperative period	No
Secondary	standard coagulation parameters		45 min after transplant unclamp	No
Secondary	standard coagulation parameters		Intensice Care Unit admission	No
Secondary	standard coagulation parameters		24 hours	No
Secondary	standard coagulation parameters		48 hours	No