Fibrinogen replacement to prevent intracranial hemorrhage in ischemic stroke patients after thrombolysis – a prospective randomized open blinded endpoint trial (FibER): rationale and methods

Journal of Stroke and Cerebrovascular Diseases 2026 Open access

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Authors: Andrea Zini, Laura Vandelli, Stefano Forlivesi, Elena Merli, Ludovica Migliaccio, Luana Gentile, Michele Romoli, Flavia Baccari, Mario Sebastiani, Francesco Nonino, Sabina Cevoli, Guido Bigliardi
DOI: 10.1016/j.jstrokecerebrovasdis.2026.108572
Cited by: 1
References: 13

Abstract

RATIONALE: Fibrinogen depletion happens soon after intravenous thrombolysis (IVT) for acute ischemic stroke, in relation to the suboptimal affinity of recombinant tissue plasminogen activator (rtPA) to thrombus fibrin. Fibrinogen depletion carries a 4-fold increase in risk of bleeding after IVT. AIM: FibER will determine if early fibrinogen repletion through intravenous infusion of fibrinogen (2 g) in case of fibrinogen depletion is safe and can prevent bleeding after IVT. SAMPLE SIZE ESTIMATES: The sample size was calculated assuming a combined rate of parenchymal hematoma at the CT scan in the treated group of 3% versus a 14% rate in the control group, for an overall absolute difference of 11%. Considering such a difference among groups, a 1:1 allocation of treatment will provide 100 patients per group to reach an 80% power to detect a statistically significant difference (p

Fields of Study & Subjects

Blood properties and coagulation Intracerebral and Subarachnoid Hemorrhage Research Acute Ischemic Stroke Management

Publication details

Journal / source
Journal of Stroke and Cerebrovascular Diseases
Publisher
Elsevier BV
Volume
35
Issue
3
Pages
108572–108572
Publication date
23 January 2026
Language
EN