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Completed

NCT Number: NCT00914589

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

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.

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Key information

Conditions

Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

catridecacog

Drug

Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute

Placebo

Drug

Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 5, 2009
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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