Phase 2 N=409 Randomized Double-blind Prevention

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

Acquired Bleeding Disorder · Cardiac Surgery Requiring Cardiopulmonary Bypass

Bottom Line

View on ClinicalTrials.gov: NCT00914589 ↗

Enrolled (actual)

409

Serious AEs

26.9%

Results posted

Nov 2014

Primary outcome: Primary: Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First — 35.2; 35.7; 34.1; 64.8 percentage (%) of subjects — p=0.8648

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: catridecacog (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novo Nordisk A/S
Primary completion: Feb 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First	35.2; 35.7; 34.1; 64.8; 64.3; 65.9	0.8648
SECONDARY Percentage of Subjects With Thromboembolic Events	9.38; 8.39; 6.52; 6.25; 6.99; 5.07	—
SECONDARY Percentage of Subjects With rFXIII Antibody Reaction	0; 1; 0	—
SECONDARY Percentage of Subjects With Critical Adverse Events	14.84; 16.78; 11.59; 6.25; 6.99; 5.07	—
SECONDARY Percentage of Subjects With Serious Adverse Events	0.00; 0.70; 0.00; 8.59; 12.59; 7.25	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00914589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.