rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets
NCT ID: NCT00222625
Last Updated: 2006-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
32 participants
INTERVENTIONAL
2005-09-30
2006-09-30
Brief Summary
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Detailed Description
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Considerable clinical interest has been given to the relationship between antiplatelet and antithrombotic treatment and ICH.
The reported incidence of major bleeding events in patients undergoing antithrombotic treatment is 5-11/1,000 patients/year, while the overall range of hemorrhages is about 62/1,000 patients/year.In the patients treated with antithrombotic drugs (oral anticoagulants or antiplatelets agent) the incidence rate of ICH has been shown higher than in the general population. Moreover, the mortality rate for both spontaneous and post-traumatic events is higher in antithrombotic treated patients than in controls. \[14,15\] rFVIIa has been successfully used to control ICH in patients with hemophilia or other coagulation disorders, and can arrest intraoperative bleeding and reverse coagulopathies in patients undergoing neurosurgical procedures.\[19\] rFVIIa has also been reported to prevent or minimize refractory bleeding in non-coagulopathic patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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rFVIIa + (vit K in AO patients)
FFP or aPCC+ vit K in AO treated patients
Eligibility Criteria
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Inclusion Criteria
* a)oral anticoagulant (INR upper than 1,4 at enrollment
* b) aspirin, whatever dosage
* Male or female subjects, age \> 18 years.
* Informed consent
Exclusion Criteria
* Patients with secondary ICH related to infarction, tumor, cerebrovenous thrombosis, thrombolysis.
* Planned neurosurgical intervention.
* Any history of haemophilia or other congenital or acquired coagulopathy requiring specific antihemorrhagic treatment.
* Acute myocardial ischaemia or acute thrombotic stroke (within one year).
* Septicemia, intravascular disseminated coagulation.
* Pregnancy.
* Limb amputation due to vascular disease or claudication within last 30 days.
* Known or suspected allergy to the trial product or related products.
* Participation in other trials within the previous year.
18 Years
ALL
No
Sponsors
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University Of Perugia
OTHER
Principal Investigators
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Alfonso Iorio
Role: PRINCIPAL_INVESTIGATOR
University Of Perugia
Locations
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A.O.R.N. San Sebastiano
Caserta, , Italy
Emergency Room
Forlì, , Italy
Emergency Department - S.Martino Hospital
Genoa, , Italy
Emergency Room - University of Messina
Messina, , Italy
Internal and Vascular Medicine - Stroke Unit - University of Perugia
Perugia, , Italy
Divisione di Neurologia
Piacenza, , Italy
Emergency Room
Ravenna, , Italy
Emergency Room
Reggio Emilia, , Italy
Stroke Unit - Policlinico Universitario Umberto I
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Tiscione Vitagliano
Role: primary
Alberto Randelli
Role: primary
Fiorella Altomonte, MD
Role: primary
Maria Gioffrè, Professor
Role: primary
Agnelli Giancarlo, Professor
Role: primary
Donata Guidetti, MD
Role: primary
Raffaele Nocenti
Role: primary
Angelo Ghirarduzzi
Role: primary
Danilo Toni, Professor
Role: primary
References
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Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
Iorio A. Iatrogenic causes of an ICH: OAT therapy. Eur J Anaesthesiol Suppl. 2008;42:8-11. doi: 10.1017/S0265021507003171.
Other Identifiers
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04 MICV AI 04
Identifier Type: -
Identifier Source: secondary_id
2005-002155-40
Identifier Type: -
Identifier Source: org_study_id