Status:
COMPLETED
Fibrinogen Replacement to Prevent Intracranial Haemorrhage in Ischemic Stroke Patients After Thrombolysis (FibER)
Lead Sponsor:
Azienda Usl di Bologna
Collaborating Sponsors:
Ministero della Salute, Italy
Conditions:
Intracranial Hemorrhages
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Fibrinogen replacement could prevent haemorrhagic complications in ischemic stroke patients with secondary post-rtPA hypofibrinogenemia
Detailed Description
Intravenous recombinant tissue plasminogen activator (rtPA) is the first recommended reperfusion therapy for acute ischemic stroke, as well as endovascular treatment in case of large vessel occlusion,...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2025
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT05300672
Start Date
February 8 2022
End Date
May 27 2025
Last Update
August 1 2025
Active Locations (1)
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1
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Italy