NCT01532661

National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 114 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhage
• Bleeding

Interventions

Type	Name	Description
OTHER	observational study	data collected by investigators

Timeline

• Start date: 2008-04-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2012-02-14
• Last updated: 2014-11-18

Locations

39 sites across 1 country: France