NCT01244425

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

A Randomized, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Fibrin Sealant VH S/D 500 S-apr (Tisseel) for Hemostasis in Subjects Undergoing Hepatic Resection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Fibrin Sealant (FS) VH S/D 500 s-apr	Dosage form: spray application; dosage frequency: single application
OTHER	Manual compression	Dosage form: surgical gauze swab; dosage frequency: single application

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-11-19
• Last updated: 2013-02-20
• Results posted: 2013-02-12

Locations

7 sites across 1 country: Germany