Clinical trial NCT00914589: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acquired Bleeding Disorder
Cardiac Surgery Requiring Cardiopulmonary Bypass
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-06-05
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First
timeFrame: measured ongoing from dosing until day 7 or discharge, whichever came first
Secondary outcomes:
measure: Percentage of Subjects With Thromboembolic Events
timeFrame: measured from screening until 5-7 weeks post Trial Drug Administration
measure: Percentage of Subjects With rFXIII Antibody Reaction
timeFrame: measured from screening until 5-7 weeks post Trial Drug Administration
measure: Percentage of Subjects With Critical Adverse Events
timeFrame: measured from screening until 5-7 weeks post Trial Drug Administration
measure: Percentage of Subjects With Serious Adverse Events
timeFrame: measured from screening until 5-7 weeks post Trial Drug Administration
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Durham
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Portland
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Allentown
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Novo Nordisk Investigational Site
state: Rhode Island
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
city: Ottawa
country: Canada
facility: Novo Nordisk Investigational Site
city: Quebec
country: Canada
facility: Novo Nordisk Investigational Site
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
city: København ø
country: Denmark
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Frankfurt am Main
country: Germany
facility: Novo Nordisk Investigational Site
city: Ludwigshafen
country: Germany
facility: Novo Nordisk Investigational Site
city: München
country: Germany
facility: Novo Nordisk Investigational Site
city: Petach Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Ramat Gan
country: Israel
facility: Novo Nordisk Investigational Site
city: Bologna
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: San Donato Milanese (MI)
country: Italy
facility: Novo Nordisk Investigational Site
city: Iwate
country: Japan
facility: Novo Nordisk Investigational Site
city: Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Lund
country: Sweden
facility: Novo Nordisk Investigational Site
city: Cambridge
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Southampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
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.
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.