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.
Conditions
Interventions
Trade Name: Tisseel Kit
Pharmaceutical Form: Powder and solvent for sealant
Sponsors
The Leeds Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of the use of Tisseel versus the absence of the use of Tisseel (or other haemostatic agent) during liver resection surgery in the prevention of post operative resection bed fluid collections;Secondary Objective: ;Primary end point(s): The primary end point is the incidence of resection bed fluid collections. | — |
Countries
United Kingdom
Outcome results
None listed