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

Baxter

Status and phase: Completed; Phase 2

Conditions: Bleeding (Oozing) in Hepatic Resection

Treatments: Other: Manual compression; Drug: Fibrin Sealant (FS) VH S/D 500 s-apr

Study type: Interventional

Funder types: Industry

Identifiers

NCT01244425

550904

2010-018480-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Pre-Operative 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

Intra-Operative 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

Pre-Operative 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

Intra-operative 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

FS VH S/D 500 s-apr

Experimental group

Description:

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.

Treatment:

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

Manual compression - Control

Active Comparator group

Description:

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.

Treatment:

Other: Manual compression