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Completed

NCT Number: NCT01563458

Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation

This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.

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Key information

Conditions

Acquired Bleeding Disorder Bleeding During/Following Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Camperdown, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled to undergo orthotopic liver transplantation
  • Liver disease classified as Child-Turcotte (Pughs modification) score B or C

Exclusion criteria

  • Previous liver transplantation
  • Scheduled multi-organ transplantation
  • Scheduled for living related donor transplantation
  • Present renal insufficiency requiring dialysis
  • Pregnancy

Treatment and study plan

activated recombinant human factor VII

Drug

120 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 120 mcg/kg single bolus administration at completion of wound closure

Placebo

Drug

Trial drug into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. Single bolus administration at completion of wound closure

Primary outcomes

  1. Total number of RBC units transfused during the perioperative period

Secondary outcomes

  1. Number of RBC units transfused by surgical phase

  2. Adverse events

  3. Changes in coagulation related parameters

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Dose Exploratory Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Reduction of Bleeding in Subjects Undergoing Orthotopic Liver Transplantation

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Mar 27, 2012
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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