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

September 19, 2006 updated by: University Of Perugia

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

Study Overview

Status

Unknown

Conditions

Intracerebral Hemorrhage

Intervention / Treatment

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

Interventional

Enrollment

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Caserta, Italy
    - Recruiting
    - A.O.R.N. San Sebastiano
    - Contact:
      
      Tiscione Vitagliano
  - Forli, Italy
    - Recruiting
    - Emergency Room
    - Contact:
      
      Alberto Randelli
  - Genua, Italy
    - Recruiting
    - Emergency Department - S.Martino Hospital
    - Contact:
      
      Fiorella Altomonte, MD
    - Principal Investigator:
      
      Paolo Moscatelli, MD
  - Messina, Italy
    - Recruiting
    - Emergency Room - University of Messina
    - Contact:
      
      Maria Gioffrè, Professor
  - Perugia, Italy
    - Recruiting
    - Internal and Vascular Medicine - Stroke Unit - University of Perugia
    - Contact:
      
      Agnelli Giancarlo, Professor
    - Principal Investigator:
      
      Agnelli Giancarlo, Professor
  - Piacenza, Italy
    - Recruiting
    - Divisione di Neurologia
    - Contact:
      
      Donata Guidetti, MD
  - Ravenna, Italy
    - Recruiting
    - Emergency Room
    - Contact:
      
      Raffaele Nocenti
  - Reggio Emilia, Italy
    - Recruiting
    - Emergency Room
  - Rome, Italy
    - Recruiting
    - Stroke Unit - Policlinico Universitario Umberto I
    - Contact:
      
      Danilo Toni, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Of Perugia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Iorio A. Iatrogenic causes of an ICH: OAT therapy. Eur J Anaesthesiol Suppl. 2008;42:8-11. doi: 10.1017/S0265021507003171.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 20, 2006

Last Update Submitted That Met QC Criteria

September 19, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

2005-002155-40
04 MICV AI 04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.