At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 239 enrolled
Drug / intervention
FS Grifols +2 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 Prospective, Single-blind, Randomized, Phase II/III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Peripheral Vascular Surgery
In Brief
A Phase 3 clinical trial evaluating FS Grifols and Manual Compression for Target Bleeding Site During Peripheral Vascular Surgery. Completed, enrolled 239 participants across 19 sites in 3 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Spain, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedMay 2008
Primary CompletionMar 2014
Study CompletionMay 2014
TodayJul 2026
First PostedMay 26, 2008
Enrollment StartFeb 1, 2008
Primary CompletionMar 1, 2014
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 18.1 years ago
Interventions
FS Grifolsbiological
Fibrin Sealant Grifols (FS Grifols). Preliminary Part (I)
FS Grifolsbiological
Fibrin Sealant Grifols (FS Grifols). Primary Part (II)
Manual Compressionprocedure
Manual Compression. Primary Part (II)