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

Sponsor

University Of Perugia (Other)

Overall Status

Unknown status

CT.gov ID

NCT00222625

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Sep 1, 2005

Study Completion Date :

Sep 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ICH in patient on treatment with one of the following:
a)oral anticoagulant (INR upper than 1,4 at enrollment
1. 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

Locations

	Site	City	Country
1	A.O.R.N. San Sebastiano	Caserta	Italy
2	Emergency Room	Forli	Italy
3	Emergency Department - S.Martino Hospital	Genua	Italy
4	Emergency Room - University of Messina	Messina	Italy
5	Internal and Vascular Medicine - Stroke Unit - University of Perugia	Perugia	Italy
6	Divisione di Neurologia	Piacenza	Italy
7	Emergency Room	Ravenna	Italy
8	Emergency Room	Reggio Emilia	Italy
9	Stroke Unit - Policlinico Universitario Umberto I	Rome	Italy