HemorrhageNOVO7NCT01532661
National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology
An observational study of Hemorrhage and Bleeding, run by University Hospital, Grenoble at 39 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage, Bleeding
- What is being tested?
- observational study
- How many people
- 114 participants
- Where
- 39 sitesFrance
- Study dates
- Apr 2008to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted in ICU after massive bleeding trauma and received rFVIIa
Who may be able to join
- people affiliated to social security
- patients admitted in ISU for haemorrhagic trauma
- patients received rFVIIa after the other treatment for bleeding control
Who cannot join
- allergy or hypersensitivity to rVIIa or one of its component
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
France39 sites
MEROUANI
Alençon
LAIGLE
Amiens
SANTRE
Annecy
MOREL
Bordeaux
SEDILLOT
Bourg-en-Bresse
BULEON
Caen
MIQUET
Chambéry
DEBIEN
Clamart
GUELON
Clermont-Ferrand
PEASE
Clichy
COOK
Créteil
NADJI
Dijon
Vinsiniti
Gap
DECLETY
Grenoble
Duranteau
Le Kremlin-Bicêtre
GARRIGUE
Lille
FLOCARD
Lyon
GARCIN
Marseille
FAVIER
Metz
CHARBIT
Montpellier
YUNG
Montpellier
AUDIBERT
Nancy
CHUPIN
Nantes
ICHAI
Nice
LEFRANT
Nîmes
JOURNOIS
Paris
LANGERON
Paris
Mateo A Loris
Paris
DAVID
Pierre-Bénite
Nanadoumgar
Poitiers
LEPOUSE
Reims
Bleichner
Rennes
GUITARD
Rouen
MARTIN
Saint-Etienne
FREYS
Strasbourg
MEAUDRE
Toulon
OLIVIER
Toulouse
LEBAS
Vannes
JAULT
Villefranche-sur-Saône
About this study
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.
Read the 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
- Being tested
- observational study
- Keywords
- TRAUMA, HAEMORRHAGIC, rVIIa, Complication of Trauma hemorrhage, bleeding, rFVIIa administration for hemorrhage after trauma
- Medical subject headings
- Hemorrhage, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
data collected by investigators
| Study group | Role | What they receive |
|---|---|---|
| observational study | haemorrhagic trauma received rFVIIa Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
use of rFVIIa in haemorrhagic trauma compared to guidelines
Deviations with European guidelines use of rFVIIa
Measured: twenty four hours
Secondary outcomes (2)
medico economic evaluation
number of patients receiving rFVIIa by year and posology by patient
Measured: one year
security and efficiency use of rFVVa
Mandatory treatments after first dose administration of rFVIIa. Patients with serious adverse events (type) and incidence
Measured: thirty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startApr 2008
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, Société Française d'Anesthésie et de Réanimation
- Responsible party
- Sponsor
- Investigators
- PAYEN JF, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532661
- Sponsor's protocol ID
- DCIC 07 20
- Acronym
- NOVO7
- Status last verified
- Nov 2014
- First submitted
- 12 Dec 2011
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16096533Martinowitz 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.
PubMed 11535886Rizoli 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.
PubMed 17184516Harrison 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.
PubMed 16096555Delannoy 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.
PubMed 17629661
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology
- ClinicalTrials.gov ID
- NCT01532661
- Acronym / sponsor ID
- NOVO7 / DCIC 07 20
- Conditions
- Hemorrhage, Bleeding
- Keywords
- TRAUMA, HAEMORRHAGIC, rVIIa, Complication of Trauma hemorrhage, bleeding, rFVIIa administration for hemorrhage after trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Société Française d'Anesthésie et de Réanimation
- Study start
- Apr 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational study | – | Other: observational studyhaemorrhagic trauma received rFVIIa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted in ICU after massive bleeding trauma and received rFVIIa
Key inclusion criteria (3 listed)
- people affiliated to social security
- patients admitted in ISU for haemorrhagic trauma
- patients received rFVIIa after the other treatment for bleeding control
Key exclusion criteria (1 listed)
- allergy or hypersensitivity to rVIIa or one of its component
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studydata collected by investigators | Other | observational study |
Primary outcome
use of rFVIIa in haemorrhagic trauma compared to guidelines
Time frame: twenty four hours
Deviations with European guidelines use of rFVIIa
2 secondary outcomes
medico economic evaluation
Time frame: one year
security and efficiency use of rFVVa
Time frame: thirty days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
- Background: PubMed 16096533Boffard 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.
- Results publication: PubMed 11535886Martinowitz 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.
- Results publication: PubMed 17184516Rizoli 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.
- Results publication: PubMed 16096555Harrison 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.
- Results publication: PubMed 17629661Delannoy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PAYEN JF, MD principal investigator
University Hospital, Grenoble
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage and Bleeding, run by University Hospital, Grenoble at 39 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
use of rFVIIa in haemorrhagic trauma compared to guidelines (time frame: twenty four hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01532661, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.