Completed PHASE2 INTERVENTIONAL 3-arm NCT00914589

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

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

Sponsor: Novo Nordisk A/S

Conditions Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass

Interventions catridecacog placebo

Updated 8 times since 2017 Last updated: Jan 23, 2017 Started: Jul 31, 2009 Primary completion: Feb 28, 2011 Completion: Feb 28, 2011

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Acquired Bleeding Disorder and Cardiac Surgery Requiring Cardiopulmonary Bypass and is currently completed. Novo Nordisk A/S leads this study, which shows 8 recorded versions since 2009 — indicating limited longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.

Status Flow

Change History

8 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2

▶ Show 3 earlier versions

May 2017 — Jun 2018 [monthly]

Completed PHASE2
Feb 2017 — May 2017 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Jul 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Novo Nordisk A/S

Data source: Novo Nordisk A/S

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Allentown, United States , Atlanta, United States , Berlin, Germany , Bologna, Italy , Cambridge, United Kingdom , Durham, United States , Frankfurt am Main, Germany , Houston, United States , København Ø, Denmark , Ludwigshafen, Germany and 20 more locations