CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 176 enrolled
Drug / intervention
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) +1 morebiological
Likely dose
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)from 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/NCT00892957
NCT00892957Phase 3Completed
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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 May 5, 2009·Updated Nov 27, 2012

In Brief

A Phase 3 clinical trial evaluating Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) and Surgical gauze pads for Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses. Completed, enrolled 176 participants across 22 sites.

Detailed Summary

The purpose of this study was to compare safety and efficacy of FS VH S/D 500 s-apr (FS) versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft placement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 5, 2009
Enrollment StartJul 1, 2009
Primary CompletionOct 1, 2010
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.2 years ago

Interventions

Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)biological

The actual dose of FS VH S/D 500 s-apr will depend on the length of the suture line and the intensity of bleeding (but shall not exceed 4 mL FS VH S/D 500 s-apr).

Surgical gauze padsother

Manual compression with surgical gauze pads