Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00914589
Recruitment Status : Completed
First Posted : June 5, 2009
Results First Posted : November 13, 2014
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief 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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 479 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FXIII17.5IU/Kg
Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow 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

Experimental: FXIII35IU/Kg
Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow 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

Placebo Comparator: Placebo
Recombinant factor XIII placebo was administered as a single dose via slow 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




Primary Outcome Measures :
  1. Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First [ Time Frame: measured ongoing from dosing until day 7 or discharge, whichever came first ]
    Proportion of patients avoiding blood products given via allogeneic transfusion. Blood products were defined as any of the following: RBC, platelets, FFP, fibrinogen concentrate and clotting factor(s) concentrate, including cryoprecipitate.


Secondary Outcome Measures :
  1. Percentage of Subjects With Thromboembolic Events [ Time Frame: measured from screening until 5-7 weeks post Trial Drug Administration ]
    Percentage of subjects with thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism) until end of trial

  2. Percentage of Subjects With rFXIII Antibody Reaction [ Time Frame: measured from screening until 5-7 weeks post Trial Drug Administration ]
    Immunogenicity as number of subjects who manifested FXIII antibody reaction until end of trial. The percentage may be derived from the number of subjects treated with rFXIII with available antibody measurement at visit 8.

  3. Percentage of Subjects With Critical Adverse Events [ Time Frame: measured from screening until 5-7 weeks post Trial Drug Administration ]
    Percentage of subjects with critical adverse events (thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism), renal dysfunction, re-operation and death) until end of trial

  4. Percentage of Subjects With Serious Adverse Events [ Time Frame: measured from screening until 5-7 weeks post Trial Drug Administration ]
    Percentage of subjects with serious adverse events until end of trial.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - Planned coronary artery bypass grafting (CABG) or CABG plus single heart valve replacement/repair or planned replacement/repair of a single heart valve

Exclusion Criteria:

  • Known intolerance to protamine
  • Known or suspected allergy to the used antifibrinolytic agent
  • Refusal to receive blood or blood product
  • Planned surgery including the aortic arch and/or descending aorta
  • Planned surgery including any implantable ventricular assist device
  • Adult congenital heart diseases
  • Two or more previous cardiac surgery procedures
  • Any known autoimmune diseases: Collagen vascular disease (Systemic lupus erythematosus, Rheumatoid arthritis, Sjögrens syndrome) - Endocrine: hyperthyroidism (Graves disease), adrenal insufficiency, Hashimoto's thyroiditis - Neurologic: Multiple sclerosis, myasthenia gravis - Skin: pemphigous vulgaris Hematologic: Pernicious anaemia, Autoimmune haemolytic anaemia - Vasculitis - Primary or secondary antiphospholipid syndrome
  • Weight above 140 kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914589


Locations
Layout table for location information
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30322-1059
United States, North Carolina
Novo Nordisk Investigational Site
Durham, North Carolina, United States, 27710
United States, Oregon
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Novo Nordisk Investigational Site
Allentown, Pennsylvania, United States, 18105
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Novo Nordisk Investigational Site
Providence, Rhode Island, United States, 02905
United States, Texas
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
Canada, Ontario
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M5B 1W8
Canada
Novo Nordisk Investigational Site
Montreal, Canada, H1T 1C8
Novo Nordisk Investigational Site
Ottawa, Canada, K1Y 4W7
Novo Nordisk Investigational Site
Quebec, Canada, G1V 4G5
Novo Nordisk Investigational Site
Toronto, Canada, M5G-2C4
Denmark
Novo Nordisk Investigational Site
København ø, Denmark, 2100
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 13353
Novo Nordisk Investigational Site
Frankfurt am Main, Germany, 60590
Novo Nordisk Investigational Site
Ludwigshafen, Germany, 67063
Novo Nordisk Investigational Site
München, Germany, 80636
Israel
Novo Nordisk Investigational Site
Petach Tikva, Israel, 49100
Novo Nordisk Investigational Site
Ramat Gan, Israel, 52621
Italy
Novo Nordisk Investigational Site
Bologna, Italy, 40138
Novo Nordisk Investigational Site
Milano, Italy, 20132
Novo Nordisk Investigational Site
San Donato Milanese (MI), Italy, 20097
Japan
Novo Nordisk Investigational Site
Iwate, Japan, 020-8505
Novo Nordisk Investigational Site
Osaka, Japan, 565-8565
Novo Nordisk Investigational Site
Tokyo, Japan, 113-843
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28007
Novo Nordisk Investigational Site
Madrid, Spain, 28034
Novo Nordisk Investigational Site
Valencia, Spain, 46026
Sweden
Novo Nordisk Investigational Site
Lund, Sweden, 221 85
United Kingdom
Novo Nordisk Investigational Site
Cambridge, United Kingdom, CB23 3RE
Novo Nordisk Investigational Site
Sheffield, United Kingdom, S5 7AU
Novo Nordisk Investigational Site
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00914589    
Other Study ID Numbers: NN1810-3540
JapicCTI-101078 ( Registry Identifier: JAPIC )
2008-006324-62 ( EudraCT Number )
First Posted: June 5, 2009    Key Record Dates
Results First Posted: November 13, 2014
Last Update Posted: March 7, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders