Ischemic stroke patients with secondary post-rtPA hypofibrinogenemia MedDRA version: 20.0 Level: HLT Classification code 10007948 Term: Central nervous system haemorrhages and cerebrovascular accidents System Organ Class: 100000004852
Conditions
Interventions
Product Name: RIASTAP
Product Code: [040170021]
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
INN or Proposed INN: 00130750
Current Sponsor code: B02BB01
Concentration un
Sponsors
AZIENDA USL DI BOLOGNA
Eligibility
Sex/Gender
All
Inclusion 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 50% than baseline level - written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: contraindication to rtPA treatment; patients who present symptomatic ICH during infusion of rt-PA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: To evaluate the safety of fibrinogen infusion in stroke patients with secondary post-rtPA 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 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;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: 24 hours after the rtPA infusion, or earlier in case of clinical deterioration, and on day 7 (or at discharge, if earlier). | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: For symptomatic cerebral haemorrhage at 24h and 7 days, as well as extracerebral haemorrhages; Clinical severity measured as NIHSS score at baseline and day 7; disability at 3 months 90 days (90 + 7) will be defined according to the mRS scale, with a good outcome defined as mRS 0-2.;Secondary end point(s): To evaluate the safety of fibrinogen infusion in stroke patients with secondary post-rtPA 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 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 | — |
Countries
Italy
Contacts
Public ContactAzienda USL di Bologna
Azienda USL di Bologna
Outcome results
None listed