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Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease

NCT01562574 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2017-01-12

No results posted yet for this study

Summary

This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary bypass (CPB) surgery for paediatric congenital heart disease.

Conditions

  • Acquired Bleeding Disorder
  • Cardiac Surgery Requiring Cardiopulmonary Bypass

Interventions

DRUG

activated recombinant human factor VII

Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered

DRUG

placebo

Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2004-08-31
Completion
2004-08-31

Countries

  • Australia

Study Locations

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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 NCT01562574 on ClinicalTrials.gov