Overview

Fibrinogen Replacement to Prevent Intracranial Haemorrhage in Ischemic Stroke Patients After Thrombolysis (FibER)

Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
0
Participant gender:
All
Summary
Fibrinogen replacement could prevent haemorrhagic complications in ischemic stroke patients with secondary post-rtPA hypofibrinogenemia
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Azienda Usl di Bologna
Collaborator:
Ministero della Salute, Italy
Criteria
Inclusion criteria:

- patients with acute ischemic stroke treated with i.v. thrombolysis (rtPA 0,9 mg/Kg,
10% in bolus and 90% in infusion in 60 minutes)

- age >18 years

- critical hypofibrinogenemia post-tPA, defined as a decrease of serum fibrinogen level
<200 mg/dl and/or a rate decrease >50% than baseline level

- written informed consent

Exclusion criteria:

- contraindication to rtPA treatment;

- patients who present symptomatic ICH during infusion of rt-PA,

- absence of written informed consent