Healthy Infants Clinical Trial
Official title:
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).
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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