CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 101 enrolled
Drug / intervention
FS VH S/D 500 s-apr, 60-seconds polymerization time +2 morebiological
Likely dose
FS VH S/D 500 s-apr, 60-seconds polymerization time 4 mLfrom 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.

Search/NCT00576420
NCT00576420Phase 2Completed
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Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 S-apr for Hemostasis in Subjects Undergoing Vascular Surgery

Baxter Healthcare Corporation·interventional·Posted Dec 19, 2007·Updated Nov 27, 2012

In Brief

A Phase 2 clinical trial evaluating FS VH S/D 500 s-apr, 60-seconds polymerization time, FS VH S/D 500 s-apr, 120-seconds polymerization time, and 1 other intervention for Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts). Completed, enrolled 101 participants across 11 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) for hemostasis in participants receiving prosthetic expanded polytetrafluoroethylene (ePTFE) conduits as compared to a control group treated by manual compression with surgical gauze pads.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 19, 2007
Enrollment StartDec 1, 2007
Primary CompletionNov 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.5 years ago

Interventions

FS VH S/D 500 s-apr, 60-seconds polymerization timebiological

FS VH S/D 500 s-apr (FS) is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr.

FS VH S/D 500 s-apr, 120-seconds polymerization timebiological

Treatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps.

Manual compression with surgical gauze padsprocedure

Treatment of the study suture line with manual compression with surgical gauze pads.