Clinical trial NCT00102037: Use of Activated Recombinant FVII in Spinal Surgery
Official title: Evaluation of Safety of Activated Recombinant FVII as an Add-On Therapy in Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acquired Bleeding Disorder
Spinal Fusion
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The purpose of this clinical research trial is to understand how safe and effective Recombinant Activated FVII is for reducing bleeding and blood transfusions in patients undergoing spinal fusion surgery.


Eligibility criteria: Inclusion Criteria:

* Elective spinal fusion surgery.

Exclusion Criteria:

* History of thrombotic disorders (myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke, disseminated intravascular coagulation or peripheral artery thrombosis)
* Any trauma within the last 3 months leading to hospitalization \> 24 hours
* Angina or known coronary artery disease

Primary outcomes:
measure: Safety variables
timeFrame: Within 30 days after surgery
Secondary outcomes:
measure: Efficacy variables
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Francisco
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Washington
country: United States
facility: Novo Nordisk Investigational Site
state: District of Columbia
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Newark
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Plano
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Sachs B, Delacy D, Green J, Graham RS, Ramsay J, Kreisler N, Kruse P, Khutoryansky N, Hu SS. Recombinant activated factor VII in spinal surgery: a multicenter, randomized, double-blind, placebo-controlled, dose-escalation trial. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2285-93. doi: 10.1097/BRS.0b013e3181557d45.
citation: 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.