Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients
NCT ID: NCT01563523
Last Updated: 2017-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
283 participants
INTERVENTIONAL
2002-03-31
2003-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Activated recombinant human factor VII
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
Placebo
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
16 Years
65 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Perth, , Australia
Novo Nordisk Investigational Site
Graz, , Austria
Novo Nordisk Investigational Site
Toronto, Ontario, Canada
Novo Nordisk Investigational Site
Paris, , France
Novo Nordisk Investigational Site
Aachen, , Germany
Novo Nordisk Investigational Site
Jerusalem, , Israel
Novo Nordisk Investigational Site
Singapore, , Singapore
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa
Novo Nordisk Investigational Site
Birmingham, , United Kingdom
Countries
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References
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Rossaint R, Christensen MC, Choong PI, Boffard KD, Riou B, Rizoli S, Kluger Y, Lefering R, Morris S; NovoSeven(R) Trauma Study Group. Cost-Effectiveness of Recombinant Activated Factor VII as Adjunctive Therapy for Bleeding Control in Severely Injured Trauma Patients in Germany. Eur J Trauma Emerg Surg. 2007 Oct;33(5):528-38. doi: 10.1007/s00068-007-6210-x. Epub 2007 Jul 20.
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.
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.
Morris S, Ridley S, Munro V, Christensen MC. Cost effectiveness of recombinant activated factor VII for the control of bleeding in patients with severe blunt trauma injuries in the United Kingdom. Anaesthesia. 2007 Jan;62(1):43-52. doi: 10.1111/j.1365-2044.2006.04896.x.
Champion HR, Fingerhut A, Escobar MA, Weiskopf RB. The role of data and safety monitoring in acute trauma resuscitation research. J Am Coll Surg. 2007 Jan;204(1):73-83. doi: 10.1016/j.jamcollsurg.2006.10.024.
Klitgaard T, Tabanera y Palacios R, Boffard KD, Iau PT, Warren B, Rizoli S, Rossaint R, Kluger Y, Riou B; NovoSeven Trauma Study Group. Pharmacokinetics of recombinant activated factor VII in trauma patients with severe bleeding. Crit Care. 2006;10(4):R104. doi: 10.1186/cc4977.
Kluger Y, Riou B, Rossaint R, Rizoli SB, Boffard KD, Choong PI, Warren B, Tillinger M. Safety of rFVIIa in hemodynamically unstable polytrauma patients with traumatic brain injury: post hoc analysis of 30 patients from a prospective, randomized, placebo-controlled, double-blind clinical trial. Crit Care. 2007;11(4):R85. doi: 10.1186/cc6092.
Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.
Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919-33. doi: 10.1111/j.1537-2995.2006.00824.x.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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F7TRAUMA-2159
Identifier Type: -
Identifier Source: org_study_id
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