Prospective, randomised trial comparing the use of Tisseel versus no fibrin sealant in preventing postoperative fluid complications following liver resection - Tisseel 1

Phase 1

• Conditions: Patients who are undergoing liver resection. The surgery can be performed for any reason: usually primary or secondary carcinoma but may be performed for other non malignant abnormality or liver disease.

• Registration Number: EUCTR2006-002332-17-GB
• Lead Sponsor: The Leeds Teaching Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-09
• Study Completion: 2011-12-22
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

• Male or female patients of any race, between 18 and 90 years of age.
• Patients due to undergo liver resection.
• Female patients of child bearing potential must have a negative urine pregnancy test prior to random assignment.
• Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study. Patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) and has given oral informed consent witnessed by an independent person.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patient has known hypersensitivity to aprotinin
• Patient has had a previous liver resection where Tisseel was used (risk of hypersensitivity)
• Patient has known abnormal liver parenchyma (significant fibrosis or cirrhosis)
• Patient has pre-operative coagulation disorders (PT > 20 seconds)
• Patient has pre-operative ascites
• Patient has platelet count of <75 000
• Patient is participating or has participated in another clinical trial and/or is taking or has been taking an investigational drug in the past 3 months
• Patient is pregnant or breast feeding
• Abnormal liver parenchyma determined intra-operatively (significant fibrosis or cirrhosis)
• Failure to achieve haemostasis without the need of sealants
• Concomitant bile duct reconstruction
• Lymphadenectomy in excess of regional

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified