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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01563523




Registration number
NCT01563523
Ethics application status
Date submitted
23/03/2012
Date registered
27/03/2012
Date last updated
13/01/2017

Titles & IDs
Public title
Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients
Scientific title
A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/ Niastase®) in the Treatment of Bleeding in Severely Injured Trauma Subjects
Secondary ID [1] 0 0
F7TRAUMA-2159
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Bleeding Disorder 0 0
Trauma 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - activated recombinant human factor VII
Treatment: Drugs - placebo

Experimental: Activated recombinant human factor VII -

Placebo comparator: Placebo -


Treatment: Drugs: activated recombinant human factor VII
Standard therapy in conjunction with three single doses of rFVIIa administered over a 3 hour period. Administered once the subject has received 8 units of PRBC

Treatment: Drugs: placebo
Standard therapy in conjunction with three single doses of placebo administered over a 3 hour period. Administered once the subject has received 8 units of PRBC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of PRBC (packed red blood cells) units (allogeneic/autologous) transfused
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Changes in coagulation related parameters: APTT (activated partial thromboplastin time), fibrinogen, D-dimers, anti thrombin-III, F1+2 (prothrombin fragment 1+2) and TAT (thrombin anti thrombin complex)
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
* Informed consent obtained from the subject and/or his/her legally authorised representative (LAR) before any trial-related activities
* Injury(ies) due to a blunt and or penetrating trauma
* Receipt of 6 units of PRBC within a 4 hour period following admittance to the trauma centre
* Receipt of 8 units of PRBC upon administration of trial drug
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prehospital cardiac arrest
* Cardiac arrest in the ER or OR
* Gunshot wound to the head
* Glasgow Coma Scale below 8
* Base deficit of above 15 mEq/l or severe acidosis
* Transfusion of 8 units or more of PRBC prior to arrival in trauma centre

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2003
Sample size
Target
Accrual to date
Final
283
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
WA, 6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
France
State/province [3] 0 0
Paris
Country [4] 0 0
Germany
State/province [4] 0 0
Aachen
Country [5] 0 0
Israel
State/province [5] 0 0
Jerusalem
Country [6] 0 0
Singapore
State/province [6] 0 0
Singapore
Country [7] 0 0
South Africa
State/province [7] 0 0
Western Cape
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Birmingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT01563523