NCT05300672CompletedPhase 3
Fibrinogen Replacement to Prevent Intracranial Haemorrhage in Ischemic Stroke Patients After Thrombolysis (FibER)
Fibrinogen Replacement to Prevent Intracranial Haemorrhage in Ischemic Stroke Patients After Thrombolysis: a Pilot Probe Randomized Controlled Trial (FibER)
Source: ClinicalTrials.gov · Last updated 1 Aug 2025
Brief summary (registry, in English)
Fibrinogen replacement could prevent haemorrhagic complications in ischemic stroke patients with secondary post-rtPA hypofibrinogenemia
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 207 (actual)
- First submitted
- 1 Mar 2022
- Start date
- 8 Feb 2022
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Azienda Usl di Bologna
- Diseases
- Stroke
- NCT number
- NCT05300672
- EU CT number
- 2024-516731-27-00
- EudraCT number
- 2020-005242-41
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 207
- From 8 Feb 2022 to the primary completion date, 31 Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- contraindication to rtPA treatment;
- patients who present symptomatic ICH during infusion of rt-PA,
- absence of written informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Not yet recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Not yet recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.