The pharmacokinetics of plasma-derived Factor XIII in children

The pharmacokinetics of plasma-derived Factor XIII in children with congential Factor XIII Deficiency.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12605000764639

Enrollment

Registered

2005-11-25

Start date

2006-02-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

To assess the pharmacokinetics in children following their "usual" dose of plasma-derived Factor XIII (Fibrogammin P). Will only be performed once on each subject. No "intervention" as such. For each individual participant, sample collection will be over a 28 day time period, following their usual infusion of Factor XIII. This infusion takes approximately 5 minutes.

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

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.

Outcome results