FIBRINOGEN REPLACEMENT TO PREVENT INTRACRANIAL HAEMORRHAGE IN ISCHEMIC STROKE PATIENTS AFTER THROMBOLYSIS: A PILOT PROBE RANDOMIZED CONTROLLED TRIAL

Phase 3

Not yet recruiting

• Conditions: Ischemic stroke patients with secondary post-rtPA hypofibrinogenemia

• Registration Number: 2024-516731-27-00
• Lead Sponsor: Azienda Unita Sanitaria Locale Di Bologna

Brief Summary

To evaluate if Fibrinogen replacement could prevent haemorrhagic complications in ischemic stroke patients with secondary post-rtPA hypofibrinogenemia.

To evaluate the efficacy of fibrinogen infusion in stroke patients with secondary post-rtPA hypofibrinogenemia in:

- sICH according NINDS, ECASS and SITS classifications

- extracerebral bleedings

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 200

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

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of fibrinogen infusion in stroke patients with secondary post-rtPA hypofibrinogenemia in reducing the rate of ICH defined as parenchymal hematoma (PH1, PH2 and remote ones)		To evaluate the efficacy of fibrinogen infusion in stroke patients with secondary post-rtPA hypofibrinogenemia in reducing the rate of ICH defined as parenchymal hematoma (PH1, PH2 and remote ones)
To evaluate the efficacy of fibrinogen infusion in stroke patients with secondary post-rtPA hypofibrinogenemia in: - sICH according NINDS, ECASS and SITS classifications. - extracerebral bleedings		To evaluate the efficacy of fibrinogen infusion in stroke patients with secondary post-rtPA hypofibrinogenemia in: - sICH according NINDS, ECASS and SITS classifications. - extracerebral bleedings

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of fibrinogen infusion in stroke patients with secondary postrtPA hypofibrinogenemia: - Serious thromboembolic adverse events at 7 days after randomization (deep vein thrombosis, pulmonary embolism, myocardial infarct, recurrence of ischemic stroke, MACE defined as all-cause mortality, nonfatal myocardial infarction, andnonfatal stroke)		To evaluate the safety of fibrinogen infusion in stroke patients with secondary postrtPA hypofibrinogenemia: - Serious thromboembolic adverse events at 7 days after randomization (deep vein thrombosis, pulmonary embolism, myocardial infarct, recurrence of ischemic stroke, MACE defined as all-cause mortality, nonfatal myocardial infarction, andnonfatal stroke)
To evaluate the efficacy of fibrinogen infusion in stroke patients with secondary post-rtPA hypofibrinogenemia in the clinical outcome defined as: - National Institutes of Health Stroke Scale score (NIHSS) at day 7 - disability at 3 months, assessed with the modified Rankin Scale (mRS). Good outcome is considered as mRS 0-2		To evaluate the efficacy of fibrinogen infusion in stroke patients with secondary post-rtPA hypofibrinogenemia in the clinical outcome defined as: - National Institutes of Health Stroke Scale score (NIHSS) at day 7 - disability at 3 months, assessed with the modified Rankin Scale (mRS). Good outcome is considered as mRS 0-2
To evaluate the diagnosis of hyperfibrinolysis detected with Rotation thromboelastometry (ROTEM) in the whole ischemic stroke population randomized in the RCT (200 patients)		To evaluate the diagnosis of hyperfibrinolysis detected with Rotation thromboelastometry (ROTEM) in the whole ischemic stroke population randomized in the RCT (200 patients)
To correlate hyperfibrinolysis with cerebral bleeding in the whole ischemic stroke population and in each arm		To correlate hyperfibrinolysis with cerebral bleeding in the whole ischemic stroke population and in each arm

Trial Locations

Locations (2)

Azienda Unita Sanitaria Locale Di Bologna; 🇮🇹 Bologna, Italy

Azienda Ospedaliero Universitaria Di Modena; 🇮🇹 Modena, Italy

Azienda Unita Sanitaria Locale Di Bologna

🇮🇹Bologna, Italy

Andrea Zini

Site contact

+390516225205

a.zini@ausl.bologna.it