search
Back to results

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

Primary Purpose

Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
catridecacog
catridecacog
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acquired Bleeding Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

FXIII17.5IU/Kg

FXIII35IU/Kg

Placebo

Arm Description

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.

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.

Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.

Outcomes

Primary Outcome Measures

Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until 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

Percentage of Subjects With Thromboembolic Events
Percentage of subjects with thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism) until end of trial
Percentage of Subjects With rFXIII Antibody Reaction
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.
Percentage of Subjects With Critical Adverse Events
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
Percentage of Subjects With Serious Adverse Events
Percentage of subjects with serious adverse events until end of trial.

Full Information

First Posted
June 3, 2009
Last Updated
January 23, 2017
Sponsor
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT00914589
Brief Title
Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
479 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FXIII17.5IU/Kg
Arm Type
Experimental
Arm Description
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.
Arm Title
FXIII35IU/Kg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
Intervention Type
Drug
Intervention Name(s)
catridecacog
Intervention Description
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
Intervention Type
Drug
Intervention Name(s)
catridecacog
Intervention Description
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
Primary Outcome Measure Information:
Title
Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First
Description
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.
Time Frame
measured ongoing from dosing until day 7 or discharge, whichever came first
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Thromboembolic Events
Description
Percentage of subjects with thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism) until end of trial
Time Frame
measured from screening until 5-7 weeks post Trial Drug Administration
Title
Percentage of Subjects With rFXIII Antibody Reaction
Description
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.
Time Frame
measured from screening until 5-7 weeks post Trial Drug Administration
Title
Percentage of Subjects With Critical Adverse Events
Description
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
Time Frame
measured from screening until 5-7 weeks post Trial Drug Administration
Title
Percentage of Subjects With Serious Adverse Events
Description
Percentage of subjects with serious adverse events until end of trial.
Time Frame
measured from screening until 5-7 weeks post Trial Drug Administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1059
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Montreal
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Ottawa
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
ZIP/Postal Code
M5G-2C4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
København ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
München
ZIP/Postal Code
80636
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
San Donato Milanese (MI)
ZIP/Postal Code
20097
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Osaka
ZIP/Postal Code
565-8565
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
113-843
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Cambridge
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24655469
Citation
Song HK, von Heymann C, Jespersen CM, Karkouti K, Korte W, Levy JH, Ranucci M, Saugstrup T, Sellke FW. Safe application of a restrictive transfusion protocol in moderate-risk patients undergoing cardiac operations. Ann Thorac Surg. 2014 May;97(5):1630-5. doi: 10.1016/j.athoracsur.2013.12.025. Epub 2014 Mar 19.
Results Reference
result
PubMed Identifier
23820174
Citation
Karkouti K, von Heymann C, Jespersen CM, Korte W, Levy JH, Ranucci M, Sellke FW, Song HK. Efficacy and safety of recombinant factor XIII on reducing blood transfusions in cardiac surgery: a randomized, placebo-controlled, multicenter clinical trial. J Thorac Cardiovasc Surg. 2013 Oct;146(4):927-39. doi: 10.1016/j.jtcvs.2013.04.044. Epub 2013 Jun 29.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

We'll reach out to this number within 24 hrs