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rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00222625
Recruitment Status : Unknown
Verified September 2006 by University Of Perugia.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : September 20, 2006
Information provided by:
University Of Perugia

Brief Summary:
Evaluation of efficacy and safety of recombinant factor VIIa versus standard therapy in preventing early haematoma growth in spontaneous acute intracerebral haemorrhage in patients treated with oral anticoagulants or antiplatelets agents

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Drug: rFVIIa + (vit K in AO patients) Drug: FFP or aPCC+ vit K in AO treated patients Phase 2

Detailed Description:

Intracerebral hemorrhage (ICH) is the deadliest, most disabling, and least treatable form of stroke. Approximately 40% of patients die within 1 month of ICH onset, and two-thirds of survivors never regain functional independence. Though guidelines for supportive care exist, there is currently no treatment that has been shown in a randomized-controlled trial to definitely improve outcome after ICH. Hematoma volume is a critical determinant of mortality and functional outcome after ICH, and early hematoma growth may be an important cause of early neurological deterioration.

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Randomized, Open, Prospective, Multicenter Pilot Study to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII in Acute Intracerebral Haemorrhage in Patients Treated With Oral Anticoagulants or Antiplatelets Agents.
Study Start Date : September 2005
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. EFFICACY: change in ICH volume from prior to dosing to 24 hours
  2. SAFETY: occurrence of clinical adverse events (Thromboembolic events, death)

Secondary Outcome Measures :
  1. Difference between groups on the modified Rankin Scale, the Barthel Index (BI), the Extended Glasgow Scale (EGCS), and the National Institute of Health's Stroke Scale (NIHSS) at one and three month follow up

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ICH in patient on treatment with one of the following:
  • 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:

  • INR below 1.4 for patients on oral anticoagulants.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00222625

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Contact: Alfonso Iorio, MD 075 578 4306

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A.O.R.N. San Sebastiano Recruiting
Caserta, Italy
Contact: Tiscione Vitagliano         
Emergency Room Recruiting
Forli, Italy
Contact: Alberto Randelli         
Emergency Department - S.Martino Hospital Recruiting
Genua, Italy
Contact: Fiorella Altomonte, MD         
Principal Investigator: Paolo Moscatelli, MD         
Emergency Room - University of Messina Recruiting
Messina, Italy
Contact: Maria Gioffrè, Professor         
Internal and Vascular Medicine - Stroke Unit - University of Perugia Recruiting
Perugia, Italy
Contact: Agnelli Giancarlo, Professor         
Principal Investigator: Agnelli Giancarlo, Professor         
Divisione di Neurologia Recruiting
Piacenza, Italy
Contact: Donata Guidetti, MD         
Emergency Room Recruiting
Ravenna, Italy
Contact: Raffaele Nocenti         
Emergency Room Recruiting
Reggio Emilia, Italy
Contact: Angelo Ghirarduzzi         
Stroke Unit - Policlinico Universitario Umberto I Recruiting
Rome, Italy
Contact: Danilo Toni, Professor         
Sponsors and Collaborators
University Of Perugia
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Principal Investigator: Alfonso Iorio University Of Perugia
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00222625    
Other Study ID Numbers: 2005-002155-40
04 MICV AI 04
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 20, 2006
Last Verified: September 2006
Keywords provided by University Of Perugia:
Intracerebral Hemorrhage
Oral Anticoagulants
Antiplatelet Agents
Recombinant Activated Factor VII
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases