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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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date September 20, 2006
Study Start Date  ICMJE September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2006)
  • EFFICACY: change in ICH volume from prior to dosing to 24 hours
  • SAFETY: occurrence of clinical adverse events (Thromboembolic events, death)
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • - EFFICACY: change in ICH volume from prior to dosing to 24 hours
  • - SAFETY: occurrence of clinical adverse events (Thromboembolic events, death)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets
Official Title  ICMJE 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.
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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Intracerebral Hemorrhage
Intervention  ICMJE
  • Drug: rFVIIa + (vit K in AO patients)
  • Drug: FFP or aPCC+ vit K in AO treated patients
Study Arms  ICMJE Not Provided
Publications * Iorio A. Iatrogenic causes of an ICH: OAT therapy. Eur J Anaesthesiol Suppl. 2008;42:8-11. doi: 10.1017/S0265021507003171. Review.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 13, 2005)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00222625
Other Study ID Numbers  ICMJE 2005-002155-40
04 MICV AI 04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Of Perugia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alfonso Iorio University Of Perugia
PRS Account University Of Perugia
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP