Fibrinogen Replacement to Prevent Intracranial Haemorrhage in Ischemic Stroke Patients After Thrombolysis: a Pilot Probe Randomized Controlled Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Unita Sanitaria Locale Di Bologna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2024-09-04

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516731-27-00

EudraCT number

2020-005242-41

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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 objectives 4

1. 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)
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
3. To evaluate the diagnosis of hyperfibrinolysis detected with Rotation thromboelastometry (ROTEM) in the whole ischemic stroke population randomized in the RCT (200 patients)
4. To correlate hyperfibrinolysis with cerebral bleeding in the whole ischemic stroke population and in each arm

Conditions and MedDRA coding

Ischemic stroke patients with secondary post-rtPA hypofibrinogenemia

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 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)
2. age >18 years
3. critical hypofibrinogenemia post-tPA, defined as a decrease of serum fibrinogen level <200 mg/dl and/or a rate decrease >50% than baseline level
4. written informed consent

Exclusion criteria 2

1. contraindication to rtPA treatment
2. patients who present symptomatic ICH during infusion of rt-PA

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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)
2. 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 endpoints 4

1. 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)
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
3. To evaluate the diagnosis of hyperfibrinolysis detected with Rotation thromboelastometry (ROTEM) in the whole ischemic stroke population randomized in the RCT (200 patients)
4. To correlate hyperfibrinolysis with cerebral bleeding in the whole ischemic stroke population and in each arm

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Unita Sanitaria Locale Di Bologna

Sponsor organisation

Azienda Unita Sanitaria Locale Di Bologna

Address

Via Altura 3

City

Bologna

Postcode

40139

Country

Italy

Scientific contact point

Organisation

Azienda Unita Sanitaria Locale Di Bologna

Contact name

Principal Investigator

Public contact point

Organisation

Azienda Unita Sanitaria Locale Di Bologna

Contact name

Principal Investigator

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications