CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 479 enrolled
Drug / intervention
catridecacog +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00914589
NCT00914589Phase 2Completed
CompareCT.gov

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

Novo Nordisk A/S·interventional·Posted Jun 5, 2009·Updated Mar 7, 2017

In Brief

A Phase 2 clinical trial evaluating catridecacog and placebo for Acquired Bleeding Disorder and Cardiac Surgery Requiring Cardiopulmonary Bypass. Completed, enrolled 479 participants across 32 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
CountriesCanada, Denmark, Germany, Israel, Italy, Japan, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 5, 2009
Enrollment StartJul 1, 2009
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.1 years ago

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