NCT00914589

Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery

A Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial on Efficacy and Safety of FXIII Replenishment With Two Different Doses of Recombinant Factor XIII Following Cardiopulmonary Bypass Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 479 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.

Conditions

• Acquired Bleeding Disorder
• Cardiac Surgery Requiring Cardiopulmonary Bypass

Interventions

Type	Name	Description
DRUG	catridecacog	Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
DRUG	catridecacog	Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
DRUG	placebo	Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2009-06-05
• Last updated: 2017-03-07
• Results posted: 2014-11-13

Locations

32 sites across 10 countries: United States, Canada, Denmark, Germany, Israel, Italy, Japan, Spain, Sweden, United Kingdom