NCT02385006

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:
  • To assess the incidence and type of coagulation disorders during the perioperative period of these two types of transplantation
  • To study correlation values between thrombolelastogram and standard coagulation parameters
  • 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2013

Enrollment Period

1.7 years

First QC Date

February 26, 2015

Last Update Submit

March 4, 2015

Conditions

Blood Coagulation

Keywords

Thromboelastographysimulatneous pancreas-kidney transplantation

Outcome Measures

Primary Outcomes (5)

  • Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring

    preoperative period

  • Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring

    45 min after transplant unclamp

  • Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring

    Intensice Care Unit admission

  • Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring

    24 hours

  • Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring

    48 hours

Secondary Outcomes (5)

  • standard coagulation parameters

    preoperative period

  • standard coagulation parameters

    45 min after transplant unclamp

  • standard coagulation parameters

    Intensice Care Unit admission

  • standard coagulation parameters

    24 hours

  • standard coagulation parameters

    48 hours

Study Arms (2)

Arm kidney transplanted

OTHER

Arm kidney transplanted: all patients who receive kidney transplantation

Biological: Blood sample

Arm pancreas-kidney transplanted

OTHER

Arm pancreas-kidney transplanted: all patients who receive pancreas-kidney transplantation

Biological: Blood sample

Interventions

Blood sampleBIOLOGICAL
Arm kidney transplantedArm pancreas-kidney transplanted

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men, women \> 18 years old
  • Kidney or pancreas-kidney recipients
  • Not opposed to research
  • With no legal protection
  • Affiliated to social security system

You may not qualify if:

  • Enrollment in an other research protocol, incompatible with the trial according to the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology and Critical Care Medicine, Edouard Herriot Hospital, Hospices Civils de Lyon

Lyon, 69003, France

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 11, 2015

Study Start

February 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 11, 2015

Record last verified: 2013-03

Locations

FR(1)