Who is sponsoring NCT00892957?

NCT00892957 is sponsored by Baxter Healthcare Corporation.

What condition does NCT00892957 study?

NCT00892957 studies Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses.

What drugs are being tested in NCT00892957?

Interventions: Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), Surgical gauze pads.

What is the status of NCT00892957?

NCT00892957 is currently COMPLETED.

Last reviewed 2012-10-26 · How we verify

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

NCT00892957 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Baxter Healthcare Corporation
Phase	Phase 3
Status	COMPLETED
Enrolment	176
Start date	2009-07
Completion	2010-11

Conditions

Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses

Interventions

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

Primary outcomes

Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application. — 4 minutes post start of treatment application
Hemostasis at the study suture line must be maintained until closure of the surgical wound.
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding — 4 minutes post start of treatment application
Investigators were shown videos of bleeding severities to standardize assessments. Moderate bleeding defined as: * Either \>25% of the suture line bleeds, or * ≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or * 1 pulsatile suture line bleeding was present.
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding — 4 minutes post start of treatment application
Investigators were shown videos of bleeding severities to standardize assessments. Severe bleeding defined as: * Either \>50% of the suture line bleeds, or * ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or * \>1 pulsatile suture line bleeding was present, or * ≥1 spurting suture line bleeding was present.

Countries

United States