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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
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.
Details
| Lead sponsor | Baxter Healthcare Corporation |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 70 |
| Start date | 2010-11 |
| Completion | 2011-07 |
Conditions
- Bleeding (Oozing) in Hepatic Resection
Interventions
- Fibrin Sealant (FS) VH S/D 500 s-apr
- Manual compression
Primary outcomes
- Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application — 4 minutes post start of treatment application
Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression. The following were regarded as treatment failures: * No hemostasis achieved at 4 minutes post treatment application (for the FS VH S/D 500 s-apr arm, the "time to hemostasis" was used; a time window of +5 seconds was acceptable for showing a success) * Additional hemostatic treatment (ie, hemostatics in addition to the randomized treatment) was required * Reapplication of FS VH S/D 500 s-apr after 4 minutes * Intraoperative rebleeding after the first 4 minutes of the observation period
Countries
Germany