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

Novo Nordisk A/S479 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

479

Conditions

Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass

Interventions

catridecacogDRUG

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

catridecacogDRUG

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

placeboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (32)

Outcomes

Primary Outcomes

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.

Time frame: measured ongoing from dosing until day 7 or discharge, whichever came first

Secondary Outcomes

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

Time frame: measured from screening until 5-7 weeks post Trial Drug Administration

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.

Time frame: measured from screening until 5-7 weeks post Trial Drug Administration

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

Time frame: measured from screening until 5-7 weeks post Trial Drug Administration

Percentage of Subjects With Serious Adverse Events

Percentage of subjects with serious adverse events until end of trial.

Time frame: measured from screening until 5-7 weeks post Trial Drug Administration

Data from ClinicalTrials.gov

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