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
|Condition or disease||Intervention/treatment||Phase|
|Healthy Infants||Other: blood withdrawal||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||270 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: healthy infants||
Other: blood withdrawal
- Thrombin generation [ Time Frame: Day 0 ]The standardized thrombin generation assay Genesia™ will be used
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
|Reims, France, 51092|