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

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ClinicalTrials.gov Identifier: NCT03007108
Recruitment Status : Completed
First Posted : January 2, 2017
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Healthy Infants Other: blood withdrawal Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Determination of Normal Range Values of Thrombin Generation Parameters in Pediatrics Population Using a New Standardized Thrombin Generation Assay
Actual Study Start Date : January 10, 2017
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: healthy infants Other: blood withdrawal



Primary Outcome Measures :
  1. Thrombin generation [ Time Frame: Day 0 ]
    The standardized thrombin generation assay Genesia™ will be used



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007108


Locations
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France
Chu Reims
Reims, France, 51092
Sponsors and Collaborators
CHU de Reims
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03007108    
Other Study ID Numbers: PO16107
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018