Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01244425 | Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection | PHASE2 | COMPLETED | 70 | — | — | Nov 1, 2010 | Jul 1, 2011 | Feb 20, 2013 | 7 | Germany |
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
| Arm | Type | Description |
|---|---|---|
| FS VH S/D 500 s-apr | EXPERIMENTAL | 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. |
| Manual compression - Control | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Fibrin Sealant (FS) VH S/D 500 s-apr | DRUG | Dosage form: spray application; dosage frequency: single application |
| Manual compression | OTHER | Dosage form: surgical gauze swab; dosage frequency: single application |
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 w...