CompletedPhase 1

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

United States43 participantsStarted 2005-10

Plain-language summary

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).

Who can participate

Age range35 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence and severity of adverse events

Timeframe: From dosing up to 5-7 weeks ± 3 days after trial product administration

Trial details

NCT IDNCT02239146

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-01

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