This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII in treatment of bleeding in patients having undergone a hematopoietic stem cell transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
11
Standard treatment of bleeding
Placebo
Two days repeated treatment regimen - low dose administered i.v. (into the vein)
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States
Novo Nordisk Investigational Site
Duarte, California, United States
Novo Nordisk Investigational Site
Baltimore, Maryland, United States
Novo Nordisk Investigational Site
St Louis, Missouri, United States
Effect on bleeding, defined as change in bleeding score
Transfusion requirements
Bleeding evaluation
Adverse events
Changes in safety coagulation parameters
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Two days repeated treatment regimen - high dose administered i.v. (into the vein)
Novo Nordisk Investigational Site
New York, New York, United States
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States
Novo Nordisk Investigational Site
Houston, Texas, United States