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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00914589
First received: June 3, 2009
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Acquired Bleeding Disorder
Cardiac Surgery Requiring Cardiopulmonary Bypass
Drug: catridecacog
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Percentage of subjects avoiding any allogeneic transfusions for seven days post-operative or until discharge, whichever comes first [ Time Frame: measured ongoing from dosing until day 7 or discharge, whichever comes first ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects with thromboembolic events [ Time Frame: measured from screening untill 5-7 weeks post Trial Drug Administration ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with rFXIII antibody reaction [ Time Frame: measured from screening untill 5-7 weeks post Trial Drug Administration ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with critical adverse events [ Time Frame: measured from screening untill 5-7 weeks post Trial Drug Administration ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with serious adverse events (thromboembolic events, renal dysfunction, re-operation) [ Time Frame: measured from screening untill 5-7 weeks post Trial Drug Administration ] [ Designated as safety issue: Yes ]

Enrollment: 479
Study Start Date: July 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: catridecacog
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
Other Name: recombinant factor XIII
Experimental: B Drug: catridecacog
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
Other Name: recombinant factor XIII
Placebo Comparator: C Drug: placebo
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects scheduled to undergo: CABG (coronary artery bypass grafting)
  • Subjects scheduled to undergo: heart valve repair/replacement
  • Subjects scheduled to undergo: CABG plus single valve repair/replacement

Exclusion Criteria:

  • Known intolerance to protamine or antifibrinolytic agents
  • Refusal to receive blood or blood products
  • Known congenital bleeding disorders
  • Planned surgery including the aortic arch/descending aorta
  • Planned surgery including any implantable ventricular assist device
  • Adult congenital heart diseases
  • Two or more previous cardiac surgery procedures
  • Any known autoimmune disease
  • Weight above 140 kg
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914589

Locations
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30322-1059
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Durham, North Carolina, United States, 27710
United States, Oregon
Novo Nordisk Clinical Trial Call Center
Portland, Oregon, United States, 97239-3011
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Allentown, Pennsylvania, United States, 18105
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Novo Nordisk Clinical Trial Call Center
Providence, Rhode Island, United States, 02905
United States, Texas
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77030
Canada, Ontario
Toronto, Ontario, Canada, M5B 1W8
Denmark
København ø, Denmark, 2100
Germany
Berlin, Germany, 13353
Israel
Petach Tikva, Israel, 49100
Italy
San Donato Milanese (MI), Italy, 20097
Japan
Tokyo, Japan, 113-843
Spain
Madrid, Spain, 28007
United Kingdom
Cambridge, United Kingdom, CB23 3RE
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00914589     History of Changes
Other Study ID Numbers: NN1810-3540, JapicCTI-101078, 2008-006324-62
Study First Received: June 3, 2009
Last Updated: June 16, 2014
Health Authority: Canada: Health Canada
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Japan: Ministry of Health, Labour and Welfare (MHLW)

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014