At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 70 enrolled
Drug / intervention
Fibrin Sealant (FS) VH S/D 500 s-apr +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Fibrin Sealant (FS) VH S/D 500 s-apr and Manual compression for Bleeding (Oozing) in Hepatic Resection. Completed, enrolled 70 participants across 7 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBleeding (Oozing) in Hepatic Resection
CountriesGermany
CollaboratorsBaxter Innovations GmbH
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2010
First PostedNov 2010
Primary CompletionJul 2011
TodayJul 2026
First PostedNov 19, 2010
Enrollment StartNov 1, 2010
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.6 years ago
Interventions
Fibrin Sealant (FS) VH S/D 500 s-aprdrug
Dosage form: spray application; dosage frequency: single application
Manual compressionother
Dosage form: surgical gauze swab; dosage frequency: single application