A RANDOMIZED, CONTROLLED, MULTICENTER PHASE 2 STUDY TO EVALUATETHE EFFICACY AND SAFETY OF FIBRIN SEALANT VH S/D 500 S-APR(TISSEEL) FORHEMOSTASIS IN SUBJECTS UNDERGOING HEPATIC RESECTION - FS VH S/D 500 S-APR IN HEPATIC RESECTIO

• Conditions: Hemostasis in hepatic resection; MedDRA version: 13.1Level: LLTClassification code 10060663Term: Surgical hemostasisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 13.1Level: LLTClassification code 10067440Term: HemostasisSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2010-018480-42-DE
• Lead Sponsor: Baxter Innovations GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of FS VH S/D 500 s-apr for hemostasis in subjects undergoing partial<br>hepatic resection, as compared to a control arm treated by manual compression with a surgical<br>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.