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

Intracerebral Hemorrhage Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00222625
• Other study ID #: 2005-002155-40
• Secondary ID: 04 MICV AI 04
• Status: Recruiting
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 19, 2006
• Start date: September 2005
• Est. completion date: September 2006

Study information

• Verified date: September 2006
• Source: University Of Perugia
• Contact: Alfonso Iorio, MD
• Phone: 075 578 4306
• Email: iorioa[@]unipg.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Drug:
• rFVIIa + (vit K in AO patients)

• FFP or aPCC+ vit K in AO treated patients

Locations

Country	Name	City	State
Italy	A.O.R.N. San Sebastiano	Caserta
Italy	Emergency Room	Forli
Italy	Emergency Department - S.Martino Hospital	Genua
Italy	Emergency Room - University of Messina	Messina
Italy	Internal and Vascular Medicine - Stroke Unit - University of Perugia	Perugia
Italy	Divisione di Neurologia	Piacenza
Italy	Emergency Room	Ravenna
Italy	Emergency Room	Reggio Emilia
Italy	Stroke Unit - Policlinico Universitario Umberto I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EFFICACY: change in ICH volume from prior to dosing to 24 hours
Primary	SAFETY: occurrence of clinical adverse events (Thromboembolic events, death)
Secondary	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