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

Phase 3

Completed

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

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

Registration Number: NCT00892957

Lead Sponsor: Baxter Healthcare Corporation

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 176

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FS VH S/D 500 s-apr	Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)	FS VH S/D 500 s-apr will be applied to the study suture line.
Manual compression with surgical gauze pads	Surgical gauze pads	Dry gauze pads will be positioned to cover the complete study suture line.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application	6 minutes post start of treatment application	Hemostasis at the study suture line must be maintained until closure of the surgical wound.
Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application	10 minutes post start of treatment application	Hemostasis at the study suture line must be maintained until closure of the surgical wound.
Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line	Intraoperative day 0	Intraoperative rebleeding at the study suture line after occurrence of hemostasis.
Percentage of Participants With Postoperative Rebleeding	Postoperative through day 30 ± 5	Any rebleeding requiring surgical re-exploration
Percentage of Participants With Graft Occlusion	post-op discharge/day 1, post-op day 14 and day 30	Determined clinically and defined as absence of blood flow through the graft.
Percentage of Participants With Infection at the Surgical Site	post-op discharge/day 1, post-op day 14 and day 30
Number of Participants With Infections by Grade	post-op discharge/day 1, post-op day 14 and day 30	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
Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline	Within 14 days prior to date of surgery
Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure	Within 14 days prior to surgery through postoperative day 14	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
Vital Signs: Heart Rate - Preoperative Baseline	Within 14 days prior to date of surgery
Percent Change in Vital Signs: Heart Rate	Within 14 days prior to surgery through postoperative day 14	Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14
Vital Signs: Respiratory Rate - Preoperative Baseline	Within 14 days prior to date of surgery
Percent Change in Vital Signs: Respiratory Rate	Within 14 days prior to surgery through postoperative day 14	Percent Change in Heart Rate Measured as: Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14
Laboratory Values Over Time: Hemoglobin	Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Hematocrit	Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Erythrocytes	Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes	Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Platelets	Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)	Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Alanine Aminotransferase (ALT)	Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Aspartate Aminotransferase (AST)	Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)	Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: International Normalized Ratio(INR)	Preoperative baseline through postoperative Day 14