National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01532661

Acronym

NOVO7

Enrollment

114

Registered

2012-02-14

Start date

2008-04-30

Completion date

2012-12-31

Last updated

2014-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding, Hemorrhage

Keywords

TRAUMA, HAEMORRHAGIC, rVIIa, Complication of Trauma hemorrhage, bleeding, rFVIIa administration for hemorrhage after trauma

Brief summary

The rFVIIa (Novoseven) has been tested in traumatic hemorrhage but its efficiency has not been proven yet in this context. A national register has been set up in France identifying the patients which received rFVIIa. Those patients had persistent and active bleeding after severe trauma despite surgery and/or interventional radiology embolization. The aim of this present study is to report the first clinical results in those situations of patients treated with rFVIIa.

Detailed description

It consists of a study of a prospective cohort in 36 centers, for 3 years, from April 1st 2008. The data of all patients who received rFVIIa in traumatic situation were collected. The investigators colligated clinical and biological parameters; have been analyzed treatment received during initial care, in intensive care before and after they received rFVIIa, length of stay in ICU, secondary effects, complications and patients outcome. ISS and TRISS score were calculated to predict mortality.

Interventions

OTHERobservational study

data collected by investigators

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* people affiliated to social security * patients admitted in ISU for haemorrhagic trauma * patients received rFVIIa after the other treatment for bleeding control

Exclusion criteria

* allergy or hypersensitivity to rVIIa or one of its component

Design outcomes

Primary

Measure	Time frame	Description
use of rFVIIa in haemorrhagic trauma compared to guidelines	twenty four hours	Deviations with European guidelines use of rFVIIa

Secondary

Measure	Time frame	Description
medico economic evaluation	one year	number of patients receiving rFVIIa by year and posology by patient
security and efficiency use of rFVVa	thirty days	Mandatory treatments after first dose administration of rFVIIa. Patients with serious adverse events (type) and incidence

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026