This is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of FCH use in subjects with congenital fibrinogen deficiency. Data will be collected on the safety and efficacy of FCH as used for the treatment of acute bleeding episodes, routine prophylaxis and perioperative bleeding in these subjects. All subjects have received FCH and may continue to receive FCH at the discretion of the treating physician / Primary Investigator according to the standard of care at the participating study site.
Study Type
OBSERVATIONAL
Enrollment
22
FCH is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma. FCH is administered as an IV infusion.
Study Site
Aurora, Colorado, United States
Study Site
Las Vegas, Nevada, United States
Study Site
Durham, North Carolina, United States
Study Site
Calgary, Alberta, Canada
Study Site
Edmonton, Alberta, Canada
Study Site
Winnipeg, Manitoba, Canada
Study Site
Halifax, Nova Scotia, Canada
Study Site
Hamilton, Ontario, Canada
Study Site
Toronto, Ontario, Canada
Study Site
Toronto, Ontario, Canada
...and 1 more locations
Percentage of participants achieving hemostatic efficacy - retrospective
The investigator's overall assessment of hemostatic efficacy of FCH from a review of the subject's historical records.
Time frame: From the subject's first use of FCH, up to approximately 20 years.
Percentage of participants achieving hemostatic efficacy - prospective
The investigator's overall assessment of hemostatic efficacy of FCH during the prospective follow-up period.
Time frame: Approximately 12 months
Percentage of participants with adverse events
Time frame: Retrospective data collection is from the subject's first use of FCH (up to approximately 20 years); Prospective data collection is from the time of informed consent up to approximately 12 months.
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