Clinical trial NCT01563458: Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation
Official title: A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Dose Exploratory Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Reduction of Bleeding in Subjects Undergoing Orthotopic Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acquired Bleeding Disorder
Bleeding During/Following Surgery
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-27
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo orthotopic liver transplantation
* Liver disease classified as Child-Turcotte (Pughs modification) score B or C

Exclusion Criteria:

* Previous liver transplantation
* Scheduled multi-organ transplantation
* Scheduled for living related donor transplantation
* Present renal insufficiency requiring dialysis
* Pregnancy

Primary outcomes:
measure: Total number of RBC units transfused during the perioperative period
Secondary outcomes:
measure: Number of RBC units transfused by surgical phase
measure: Adverse events
measure: Changes in coagulation related parameters
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Novo Nordisk Investigational Site
city: Heidelberg
country: Australia
facility: Novo Nordisk Investigational Site
city: Vancouver
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: London
country: Canada
facility: Novo Nordisk Investigational Site
city: Quebec
country: Canada
facility: Novo Nordisk Investigational Site
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
city: Clichy
country: France
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Essen
country: Germany
facility: Novo Nordisk Investigational Site
city: Baracaldo
country: Spain
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Birmingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Edinburgh
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leeds
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Lodge JP, Jonas S, Jones RM, Olausson M, Mir-Pallardo J, Soefelt S, Garcia-Valdecasas JC, McAlister V, Mirza DF; rFVIIa OLT Study Group. Efficacy and safety of repeated perioperative doses of recombinant factor VIIa in liver transplantation. Liver Transpl. 2005 Aug;11(8):973-9. doi: 10.1002/lt.20470.
citation: 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.