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FibER: Fibrinogen Replacement in Ischemic Stroke
NCT05300672Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2022
- Primary completion
- Dec 2024
- Countries
- 1
- Sponsor
- Azienda USL di Bologna
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- Fibrinogen human
- Conditions
- ischemic stroke
01
Overview
Phase 3, randomised, open-label trial of Fibrinogen human in ischemic stroke (2 arms), sponsored by Azienda USL di Bologna. Primary endpoint: Intracranial hemorrhage defined as parenchymal hematoma at 7 days. Started Feb 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Fibrinogen Infusion
Fibrinogen infusion (2g)
No Fibrinogen Infusion
No fibrinogen infusion
03
Who it enrols
Adult patients with acute ischemic stroke treated with IV rtPA who develop critical hypofibrinogenemia (<200 mg/dl or >50% decrease).
04
Endpoints
Primary
Intracranial hemorrhage defined as parenchymal hematoma
Secondary
Symptomatic intracranial hemorrhage
Extracranial bleedings
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