Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Cardiac Surgery Requiring Cardiopulmonary Bypass; Acquired Bleeding Disorder

Treatments: Drug: placebo; Drug: catridecacog

Study type: Interventional

Funder types: Industry

Identifiers

NCT02239146

F13CARD-1660

2005-000729-40 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB).

Enrollment: 43 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is undergoing his/her first myocardial revascularization

Exclusion criteria

• Previous participation (randomisation and dosing) in this trial
• Subject has a history of cerebrovascular event (including thrombotic or haemorrhagic stroke or transient ischaemic attack (TIA)) and/or extra-myocardial thromboembolic events, e.g., deep vein thrombosis (DVT) or pulmonary embolus (PE)
• Subject required a pre-operative (within 30 days) transfusion of any blood and/or blood product
• Subject has a current atrial fibrillation or history of atrial fibrillation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups, including a placebo group

rFXIII

Experimental group

Treatment:

Drug: catridecacog

Placebo

Placebo Comparator group

Treatment:

Drug: placebo