Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
| Société Française d'Anesthésie et de Réanimation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| observational study | haemorrhagic trauma received rFVIIa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observational study | Other | data collected by investigators |
|
| Measure | Description | Time Frame |
|---|---|---|
| use of rFVIIa in haemorrhagic trauma compared to guidelines | Deviations with European guidelines use of rFVIIa | twenty four hours |
| Measure | Description | Time Frame |
|---|---|---|
| medico economic evaluation | number of patients receiving rFVIIa by year and posology by patient | one year |
| security and efficiency use of rFVVa | Mandatory treatments after first dose administration of rFVIIa. Patients with serious adverse events (type) and incidence |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All patients admitted in ICU after massive bleeding trauma and received rFVIIa
Not provided
| Name | Affiliation | Role |
|---|---|---|
| PAYEN JF, MD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MEROUANI | Alençon | France | ||||
| LAIGLE |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16096533 | Background | Boffard KD, Riou B, Warren B, Choong PI, Rizoli S, Rossaint R, Axelsen M, Kluger Y; NovoSeven Trauma Study Group. Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebo-controlled, double-blind clinical trials. J Trauma. 2005 Jul;59(1):8-15; discussion 15-8. doi: 10.1097/01.ta.0000171453.37949.b7. | |
| 11535886 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| thirty days |
| Amiens |
| France |
| SANTRE | Annecy | France |
| MOREL | Bordeaux | France |
| SEDILLOT | Bourg-en-Bresse | France |
| BULEON | Caen | France |
| MIQUET | Chambéry | France |
| DEBIEN | Clamart | France |
| GUELON | Clermont-Ferrand | France |
| PEASE | Clichy | France |
| COOK | Créteil | France |
| NADJI | Dijon | France |
| Vinsiniti | Gap | France |
| DECLETY | Grenoble | France |
| Duranteau | Le Kremlin-Bicêtre | France |
| GARRIGUE | Lille | France |
| FLOCARD | Lyon | France |
| GARCIN | Marseille | France |
| FAVIER | Metz | France |
| CHARBIT | Montpellier | France |
| YUNG | Montpellier | France |
| AUDIBERT | Nancy | France |
| CHUPIN | Nantes | France |
| ICHAI | Nice | France |
| LEFRANT | Nîmes | France |
| JOURNOIS | Paris | France |
| LANGERON | Paris | France |
| Mateo A Loris | Paris | France |
| DAVID | Pierre-Bénite | France |
| Nanadoumgar | Poitiers | France |
| LEPOUSE | Reims | France |
| Bleichner | Rennes | France |
| GUITARD | Rouen | France |
| MARTIN | Saint-Etienne | France |
| FREYS | Strasbourg | France |
| MEAUDRE | Toulon | France |
| OLIVIER | Toulouse | France |
| LEBAS | Vannes | France |
| JAULT | Villefranche-sur-Saône | France |
| Result |
| Martinowitz U, Kenet G, Segal E, Luboshitz J, Lubetsky A, Ingerslev J, Lynn M. Recombinant activated factor VII for adjunctive hemorrhage control in trauma. J Trauma. 2001 Sep;51(3):431-8; discussion 438-9. doi: 10.1097/00005373-200109000-00002. |
| 17184516 | Result | Rizoli SB, Boffard KD, Riou B, Warren B, Iau P, Kluger Y, Rossaint R, Tillinger M; NovoSeven Trauma Study Group. Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials. Crit Care. 2006;10(6):R178. doi: 10.1186/cc5133. |
| 16096555 | Result | Harrison TD, Laskosky J, Jazaeri O, Pasquale MD, Cipolle M. "Low-dose" recombinant activated factor VII results in less blood and blood product use in traumatic hemorrhage. J Trauma. 2005 Jul;59(1):150-4. doi: 10.1097/01.ta.0000171470.39742.8e. |
| 17629661 | Result | Delannoy B, Levrat A, Chamouard V, Aulagner G, Perdrix JP, Negrier C, Allaouchiche B. [Off label use of recombinant activated factor VII: a practice survey]. Ann Fr Anesth Reanim. 2007 Sep;26(9):774-9. doi: 10.1016/j.annfar.2007.06.001. Epub 2007 Jul 16. French. |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided