Age-dependency of Thrombin Generation Using a New Standardized Assay (TGT)

February 12, 2018 updated by: CHU de Reims

Determination of Normal Range Values of Thrombin Generation Parameters in Pediatrics Population Using a New Standardized Thrombin Generation Assay

The aim of this study is to establish normal values of thrombin generation assay parameters in pediatrics, according to different age groups. The standardized thrombin generation assay "Genesia™" will be used. Different age groups of healthy children will be recruited : neonates, 1-3 months, 3-6 months, 6-12 months, 1-2 years, 2-6 years, 6-12 years, and 12-15 years old. Adults values will be obtained (healthy adults > 18 years old).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Materials and Methods Collection of blood samples Blood samples of 240 healthy children will be obtained from the blood that will be collected for the routine coagulation screening (in neonates and in children < 18 months) or at the time of surgery in children aged > 18 months. Healthy neonates will be recruited by the neonatologists. Children aged from 1 month to 15 years will be included by anesthesiologists before minor elective surgery such as tonsillectomy, adenoidectomy, phimosis or oral surgery. Additionally, blood from adults referred for thrombophilia testing will be studied. This study was approved by French authorities (ANSM and CPP). Inform consent will be obtained from all participants. Blood will be collected into plastic tubes containing sodium citrate (0.106 M, tubes from "Starstedt"). Platelet poor plasma will be obtained by two centrifugations for 10 minutes at 2500 g at room temperature and stored at - 70°C until further examination.

Statistical analysis Statistical analysis will be performed as 1) a descriptive analysis (frequency and percentage for qualitative data, mean, SD and centiles for quantitative data), and 2) a comparison analysis (student, Mann-Withney, Kruskall- Wallis).

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • Chu Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent from parents of children
  • Informed consent from patients in the case of adults refered for thrombophilia testing
  • Affiliation to the French Health Social System

Exclusion Criteria:

  • weight < 3250 g
  • Patients under law protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: healthy infants
Other: blood withdrawal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombin generation
Time Frame: Day 0
The standardized thrombin generation assay Genesia™ will be used
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • PO16107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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