The pharmacokinetics of plasma-derived Factor XIII in childre

Not Applicable

• Conditions: Congenital Factor XIII deficiency; Other -

• Registration Number: ACTRN12605000764639
• Lead Sponsor: Department of Clinical Haematology, Royal Children's Hospital, Parkville, Victoria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Proven FXIII deficiencypatient registered in the Haemophilia program at the Royal Children's HospitalInformed consent obtainedpatients are receiving or have previously received Fibrogammin P as part of their treatment regime.

Exclusion Criteria

Patients with haematocrit <35%patients with platelet count <100active bleeding at the time of testingpatient unable to cooperate with study procedures.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the pharmacokinetics of FXIII in children and compare to literature based on adults. [Samples will be collected at eight specified time intervals, spread over 28 days. Timing of samples has been adapted from recommended guidelines from the Scientific and Standardization Committee of the International Society of Thrombosis and Haemostasis. Once all samples are collected for each individual, the data will used to determine the FXIII recovery and FXIII half-life.]

Secondary Outcome Measures

Name	Time	Method
To individualise and optomise treatment regimes in children.[]