NCT03007108

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

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

First Submitted

Initial submission to the registry

December 27, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

January 10, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

12 months

First QC Date

December 27, 2016

Last Update Submit

February 12, 2018

Conditions

Healthy Infants

Outcome Measures

Primary Outcomes (1)

  • Thrombin generation

    The standardized thrombin generation assay Genesia™ will be used

    Day 0

Study Arms (1)

healthy infants

EXPERIMENTAL
Other: blood withdrawal

Interventions

blood withdrawalOTHER
healthy infants

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • weight \< 3250 g
  • Patients under law protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2016

First Posted

January 2, 2017

Study Start

January 10, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

February 13, 2018

Record last verified: 2018-02

Locations

FR(1)