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

NCT00914589 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 479

Last updated 2017-03-07

Study results available
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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.

Conditions

  • Acquired Bleeding Disorder
  • Cardiac Surgery Requiring Cardiopulmonary Bypass

Interventions

DRUG

catridecacog

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

DRUG

catridecacog

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

DRUG

placebo

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

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States
  • Canada
  • Denmark
  • Germany
  • Israel
  • Italy
  • Japan
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00914589 on ClinicalTrials.gov