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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrinogen Concentrate, Human (FCH) | A cohort of subjects who have retrospectively received FCH for the treatment of bleeding, routine prophylaxis and/or use in surgery, and who may continue to prospectively receive FCH at the discretion of the treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FCH | Biological | FCH is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma. FCH is administered as an IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the subject's first use of FCH, up to approximately 20 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving hemostatic efficacy - prospective | The investigator's overall assessment of hemostatic efficacy of FCH during the prospective follow-up period. | Approximately 12 months |
| Percentage of participants with adverse events |
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Inclusion Criteria:
Exclusion Criteria:
None
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A cohort of subjects who have retrospectively received FCH for the treatment of bleeding, routine prophylaxis and/or use in surgery, and who may continue to prospectively receive FCH at the discretion of the treating physician.
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| Name | Affiliation | Role |
|---|---|---|
| Program Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Aurora | Colorado | 80045 | United States | ||
| Study Site |
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|
| 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. |
| Las Vegas |
| Nevada |
| 89109 |
| United States |
| Study Site | Durham | North Carolina | 27705 | United States |
| Study Site | Calgary | Alberta | T2N 2T9 | Canada |
| Study Site | Edmonton | Alberta | T6G 2H7 | Canada |
| Study Site | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Study Site | Halifax | Nova Scotia | B3H2Y9 | Canada |
| Study Site | Hamilton | Ontario | L8S 3Z5 | Canada |
| Study Site | Toronto | Ontario | M5B 1W8 | Canada |
| Study Site | Toronto | Ontario | M5G 1X8 | Canada |
| Study Site | Montreal | Quebec | H3T 1C5 | Canada |
| ID | Term |
|---|---|
| D005340 | Fibrinogen |
| ID | Term |
|---|---|
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001779 | Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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