FS VH S/D 500 S-apr in Vascular Surgery

Baxter Healthcare Corporation176 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

176

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)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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: Preoperative inclusion criteria: * Subjects undergoing vascular surgery (ie, conduit placement with an ePTFE graft), including arterio-arterial bypasses, including: * axillo-femoral * axillo-bifemoral * aorto-bifemoral * ilio-femoral * femoro-femoral * ilio-popliteal * femoro-popliteal (including below knee) * femoro-tibial vessel bypass * arterio-venous shunting for dialysis access in the upper or lower extremity * Signed informed consent * Subject is of childbearing potential, presents with a negative serum or urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study. * Subject is willing and able to comply with the requirements of the protocol. Intraoperative inclusion criterion: * Suture line bleeding eligible for study treatment is present after surgical hemostasis (ie, suturing). (A definition of eligible suture line bleeding is provided in the study protocol.) Exclusion Criteria: Preoperative exclusion criteria: * Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed) * Congenital coagulation disorders * Prior kidney transplantation * Heparin-induced thrombocytopenia * Known hypersensitivity to heparin * Known hypersensitivity to aprotinin or other components of the product * Known severe congenital or acquired immunodeficiency (eg, HIV infection or long-term treatment with immunosuppressive drugs (eg, organ transplantation patients) * Prior radiation therapy to the operating field * Severe local inflammation at the operating field * Subject is pregnant or lactating at the time of enrollment * Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study * Subject has previously participated in this study (Protocol No.: 550801), ie, each subject can only be enrolled once. Intraoperative Exclusion Criteria: * Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure * Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria, (eg, abandonment of ePTFE graft placement)

Locations (22)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.

Hemostasis at the study suture line must be maintained until closure of the surgical wound.

Time frame: 4 minutes post start of treatment application

Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding

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.

Time frame: 4 minutes post start of treatment application

Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding

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.

Time frame: 4 minutes post start of treatment application

Secondary Outcomes

Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application

Hemostasis at the study suture line must be maintained until closure of the surgical wound.

Time frame: 6 minutes post start of treatment application

Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application

Hemostasis at the study suture line must be maintained until closure of the surgical wound.

Time frame: 10 minutes post start of treatment application

Data from ClinicalTrials.gov

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Unnamed facility

Fresno, California, United States

Unnamed facility

Orange, California, United States

Unnamed facility

Washington D.C., District of Columbia, United States

Unnamed facility

Jacksonville, Florida, United States

Unnamed facility

Melbourne, Florida, United States

Unnamed facility

Fort Wayne, Indiana, United States

Unnamed facility

Lexington, Kentucky, United States

Unnamed facility

Baton Rouge, Louisiana, United States

...and 12 more locations

Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line

Intraoperative rebleeding at the study suture line after occurrence of hemostasis.

Time frame: Intraoperative day 0

Percentage of Participants With Postoperative Rebleeding

Any rebleeding requiring surgical re-exploration

Time frame: Postoperative through day 30 ± 5

Percentage of Participants With Graft Occlusion

Determined clinically and defined as absence of blood flow through the graft.

Time frame: post-op discharge/day 1, post-op day 14 and day 30

Percentage of Participants With Infection at the Surgical Site

Time frame: post-op discharge/day 1, post-op day 14 and day 30

Number of Participants With Infections by Grade

Infections were recorded according to: * Grade I: only dermis affected * Grade II: infection invades subcutaneous region but not the arterial implant * Grade III: the arterial implant is infected

Time frame: post-op discharge/day 1, post-op day 14 and day 30

Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline

Time frame: Within 14 days prior to date of surgery

Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure

Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

Time frame: Within 14 days prior to surgery through postoperative day 14

Vital Signs: Heart Rate - Preoperative Baseline

Time frame: Within 14 days prior to date of surgery

Percent Change in Vital Signs: Heart Rate

Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

Time frame: Within 14 days prior to surgery through postoperative day 14

Vital Signs: Respiratory Rate - Preoperative Baseline

Time frame: Within 14 days prior to date of surgery

Percent Change in Vital Signs: Respiratory Rate

Percent Change in Heart Rate Measured as: Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

Time frame: Within 14 days prior to surgery through postoperative day 14

Laboratory Values Over Time: Hemoglobin