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Completed

NCT Number: NCT01532661

National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology

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.

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Key information

Conditions

Hemorrhage Bleeding Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MEROUANI, Alençon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

data collected by investigators

Primary outcomes

  1. use of rFVIIa in haemorrhagic trauma compared to guidelines

    Time frame: twenty four hours

    Deviations with European guidelines use of rFVIIa

Secondary outcomes

  1. medico economic evaluation

    Time frame: one year

    number of patients receiving rFVIIa by year and posology by patient

  2. security and efficiency use of rFVVa

    Time frame: thirty days

    Mandatory treatments after first dose administration of rFVIIa. Patients with serious adverse events (type) and incidence

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Novo Nordisk A/S
  • Société Française d'Anesthésie et de Réanimation

Registry information

Acronym: NOVO7

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 14, 2012
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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