Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Novo Nordisk A/S829 enrolled

Overview

This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America. The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

829

Conditions

Acquired Bleeding Disorder Intracerebral Haemorrhage

Interventions

eptacog alfa (activated)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (167)

Outcomes

Primary Outcomes

Reducing disability and improving clinical outcome

Time frame: After 3 months

Secondary Outcomes

Reducing mortality

Reducing hematoma growth

Data from ClinicalTrials.gov

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