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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University Of Perugia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Of Perugia
ClinicalTrials.gov Identifier:
NCT00222625
First received: September 13, 2005
Last updated: September 19, 2006
Last verified: September 2006
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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.

Resource links provided by NLM:


Further study details as provided by University Of Perugia:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 32
Study Start Date: September 2005
Estimated Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222625

Contacts
Contact: Alfonso Iorio, MD 075 578 4306 iorioa@unipg.it

Locations
Italy
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
Investigators
Principal Investigator: Alfonso Iorio University Of Perugia
  More Information

No publications provided by University Of Perugia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00222625     History of Changes
Other Study ID Numbers: 2005-002155-40, 04 MICV AI 04
Study First Received: September 13, 2005
Last Updated: September 19, 2006
Health Authority: Italy: Ministry of Health

Keywords provided by University Of Perugia:
Intracerebral Hemorrhage
Oral Anticoagulants
Antiplatelet Agents
Recombinant Activated Factor VII

Additional relevant MeSH terms:
Cerebral Hemorrhage
Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Anticoagulants
Platelet Aggregation Inhibitors
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014