Hemostasis in hepatic resection MedDRA version: 13.1 Level: LLT Classification code 10060663 Term: Surgical hemostasis System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 13.1 Level: LLT Classification code 10067440 Term: Hemostasis System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: TISSEEL Ready to use
Product Name: TISSEEL
Pharmaceutical Form: Sealant
CAS Number: 9001-32-5
Other descriptive name: HUMAN FIBRINOGEN
Concentration unit: mg/ml milligram(s)/millilitre
Co
Sponsors
Baxter Innovations GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Preoperative inclusion criteria: • Signed informed consent obtained from the subject before any study-related activities • Subject’s age is 18 years or above • Subject will undergo planned, elective resection of at least 1 anatomical segment of the liver for any reason by laparotomy • Subject is willing and able to comply with the requirements of the protocol • Female subjects of childbearing potential must present with a negative serum or urine pregnancy test within 72 hours before the elective liver resection • Female subjects of childbearing potential must agree to employ adequate birth control measures for the duration of their participation in the study Intraoperative inclusion criteria (before randomization): • Resection of at least 1 anatomical segment of the liver has been performed • Oozing from the cut surface of the liver persists after conventional resection procedure and primary control of arterial and venous bleeding by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation • Need for additional supportive hemostatic treatment to stop bleeding (i.e. diffuse oozing) of the liver resection area 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: Preoperative exclusion criteria: • Subject needs emergency liver surgery • Subject will undergo liver resection via laparoscopic procedure • Subject has known congenital coagulation disorder (e.g. hemophilia) • Subject has known hypersensitivity to any ingredient of the investigational medicinal product • Suspected inability or unwillingness of the subject to comply with trial procedures • If female, subject is pregnant or lactating at the time of study enrollment • Subject has already participated in this study (each subject can only be enrolled once) • Subject has participated in another clinical study involving an IP or investigational device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study Intraoperative Exclusion Criteria (before randomization): • Occurrence of any severe surgical complication that require resuscitation or deviation from the planned surgical procedure. • Disseminated intravascular coagulopathy (DIC) • Application of any topical hemostatic material on the resection surface of the liver prior to application of the study treatment • Radiofrequency precoagulation of the liver resection surface, except focal use of radiofrequency as primary hemostatic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of FS VH S/D 500 s-apr for hemostasis in subjects undergoing partial hepatic resection, as compared to a control arm treated by manual compression with a surgical gauze swab.;Secondary Objective: To assess safety, i.e. adverse events.;Primary end point(s): The proportion of subjects with intraoperative hemostasis at 4 minutes. Time recording will start with treatment application. Hemostasis must be maintained until surgical closure. | — |
Countries
Germany
Outcome results
None listed