At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 56 enrolled
Drug / intervention
Fibrocaps (fibrin sealant) +1 morebiological
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 Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety and Study of Topical Fibrocaps™ and Gelatin Sponge in Surgical Hemostasis in the Netherlands
In Brief
A Phase 2 clinical trial evaluating Fibrocaps (fibrin sealant) and Gelatin sponge for Postoperative Hemorrhage. Completed, enrolled 56 participants across 1 site.
Detailed Summary
A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery. The study will enroll 42 eligible subjects and be conducted at 4 sites in the Netherlands.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Hemorrhage
CountriesNetherlands
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2010
First PostedDec 2010
Primary CompletionSep 2011
Study CompletionOct 2011
TodayJul 2026
First PostedDec 8, 2010
Enrollment StartDec 1, 2010
Primary CompletionSep 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.6 years ago
Interventions
Fibrocaps (fibrin sealant)biological
human thrombin and fibrinogen topical powder
Gelatin spongedevice
absorbable gelatin sponge for topical use