Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Novo Nordisk A/S400 enrolled

Overview

This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Acquired Bleeding Disorder Intracerebral Haemorrhage

Interventions

activated recombinant human factor VIIDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Spontaneous intracranial haemorrhage (ICH) within 3 hours after first symptom Exclusion Criteria: * Patients with secondary ICH * Pre-existing disability * Haemophilia

Locations (15)

Novo Nordisk Investigational Site

Melbourne, Australia

Novo Nordisk Investigational Site

Graz, Austria

Novo Nordisk Investigational Site

Antwerp, Belgium

Outcomes

Primary Outcomes

Reducing haematoma growth

Secondary Outcomes

Reducing disability and improving clinical outcome

Data from ClinicalTrials.gov

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