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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
University Of Perugia

September 13, 2005
September 22, 2005
September 20, 2006
September 2005
Not Provided
  • EFFICACY: change in ICH volume from prior to dosing to 24 hours
  • SAFETY: occurrence of clinical adverse events (Thromboembolic events, death)
  • - EFFICACY: change in ICH volume from prior to dosing to 24 hours
  • - SAFETY: occurrence of clinical adverse events (Thromboembolic events, death)
Complete list of historical versions of study NCT00222625 on ClinicalTrials.gov Archive Site
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
Same as current
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rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets
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.
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

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Intracerebral Hemorrhage
  • Drug: rFVIIa + (vit K in AO patients)
  • Drug: FFP or aPCC+ vit K in AO treated patients
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
32
Same as current
September 2006
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00222625
2005-002155-40
04 MICV AI 04
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University Of Perugia
Not Provided
Principal Investigator: Alfonso Iorio University Of Perugia
University Of Perugia
September 2006

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