Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection

NCT ID: NCT01244425

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-07-31

Brief Summary

The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local bleeding (i.e. oozing) in hepatic resection surgery when standard surgical techniques are insufficient.

Conditions

Bleeding (Oozing) in Hepatic Resection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FS VH S/D 500 s-apr

Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.

Group Type: EXPERIMENTAL

Fibrin Sealant (FS) VH S/D 500 s-apr

Intervention Type: DRUG

Dosage form: spray application; dosage frequency: single application

Manual compression - Control

A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.

Group Type: ACTIVE_COMPARATOR

Manual compression

Intervention Type: OTHER

Dosage form: surgical gauze swab; dosage frequency: single application

Interventions

Fibrin Sealant (FS) VH S/D 500 s-apr

Dosage form: spray application; dosage frequency: single application

Intervention Type: DRUG

Manual compression

Dosage form: surgical gauze swab; dosage frequency: single application

Intervention Type: OTHER

Other Intervention Names

Tisseel

Eligibility Criteria

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 time of their participation in the study

• 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

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 investigational product or investigational device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational product or investigational device during the course of this study

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Innovations GmbH

INDUSTRY

Sponsor Role: collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Baxter BioScience Medical Director, MD

Role: STUDY_DIRECTOR

Baxter Healthcare Corporation

Locations

Berlin, , Germany

Essen, , Germany

Hanover, , Germany

Heidelberg, , Germany

Jena, , Germany

Leipzig, , Germany

Tübingen, , Germany

Countries

Germany

Other Identifiers

2010-018480-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

550904

Identifier Type: -

Identifier Source: org_study_id