Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy

Novo Nordisk A/S235 enrolled

Overview

This trial is conducted in Asia. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in cirrhotic patients scheduled to undergo partial hepatectomy due to liver cancer or benign tumours.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

235

Conditions

Acquired Bleeding Disorder Cirrhosis

Interventions

activated recombinant human factor VIIDRUG

An initial bolus dose of 50 mcg/kg body weight (BW) followed by 50 mcg/kg BW every second hour until completion of surgery

activated recombinant human factor VIIDRUG

An initial bolus dose of 100 mcg/kg body weight (BW) followed by 100 mcg/kg BW every second hour until completion of surgery

placeboDRUG

An initial placebo bolus dose followed by placebo every second hour until completion of surgery

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Cirrhosis (Child-Turcotte Score A, B, or C) * Scheduled to undergo partial hepatectomy due to liver cancer or benign tumours Exclusion Criteria: * Portal vein thrombosis * Clinically documented DVT (deep venous thrombosis) * Clinically documented symptoms of severe cardiovascular disease and/or previous myocardial/pulmonary infarction or stroke * Present renal insufficiency requiring dialysis

Locations (7)

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Novo Nordisk Investigational Site

Shanghai, Shanghai Municipality, China

Novo Nordisk Investigational Site

Beijing, China

Novo Nordisk Investigational Site

Taipei, Taiwan

Outcomes

Primary Outcomes

The RBC transfusion requirements

Secondary Outcomes

Number of transfusion product units

Change in coagulation-related parameters

Adverse events

Data from ClinicalTrials.gov

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