Fibrin Sealant Vascular Surgery Study

Phase 2

Completed

Conditions: Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)

Interventions: Biological: FS VH S/D 500 s-apr, 60-seconds polymerization time
Biological: FS VH S/D 500 s-apr, 120-seconds polymerization time
Procedure: Manual compression with surgical gauze pads

Registration Number: NCT00576420

Lead Sponsor: Baxter Healthcare Corporation

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

Inclusion Criteria

Male or female of all ages
Subject undergoing peripheral vascular surgery, ie, conduit placement with an ePTFE graft such as arterio-arterial bypasses [including: axillo-femoral, ilio-femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass], or arteriovenous dialysis access shunt in the upper or lower extremity.
Signed informed consent

Intraoperative inclusion criterion:

Suture line bleeding eligible for study treatment is present after surgical hemostasis (i.e., suturing).

Suture line bleeding eligible for study treatment is defined as: any suture line bleeding that would prevent immediate closure of the wound and require treatment of the bleeding first, and on a scale of mild, moderate, and severe, the suture line bleeding is assessed as moderate or severe. (Moderate is defined as: either more than 25% of the suture line bleeds, or at least 5 suture line bleedings are present, if counting of suture line bleedings is possible, or one pulsatile suture line bleeding is present. Severe is defined as: either more than 50% of the suture line bleeds, or at least 10 suture line bleedings present, if counting of suture line bleedings is possible, or more than one pulsatile suture line bleedings are present, or at least one spurting suture line bleeding is present.)

Note: Bleedings that can be treated with additional sutures are not appropriate for the study. Such anastomoses should receive additional sutures, be re-categorized, and if they still comply with the inclusion criteria, be randomized.

Exclusion Criteria

Subjects concurrently participating in another clinical study treatment with another investigational drug or device within the last 30 days
Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)
Arterio-arterial bypasses with more than 2 anastomoses (e.g., aorto-bifemoral, axillo-bifemoral etc.)
Pregnant or lactating women
Congenital coagulation disorders
Prior kidney transplantation
Heparin-induced thrombocytopenia
Known prior exposure to aprotinin within the last 12 months
Known hypersensitivity to aprotinin or other components of the product
Known severe congenital or acquired immunodeficiency (e.g., HIV infection or long term treatment with immunosuppressive drugs)
Prior radiation therapy to the operating field
Severe local inflammation at the operating field.

Intraoperative exclusion criterion:

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, (e.g. 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 - 60-Seconds	FS VH S/D 500 s-apr, 60-seconds polymerization time	Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) will be applied to the study suture line, 60-second polymerization time
FS VH S/D 500 s-apr - 120-Seconds	FS VH S/D 500 s-apr, 120-seconds polymerization time	FS VH S/D 500 s-apr will be applied to the study suture line, 120-second polymerization time
Control Group- Manual compression with surgical gauze pads	Manual compression with surgical gauze pads	Treatment of the study-suture line will be manual compression with surgical gauze pads.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.	4 minutes post start of treatment application	Hemostasis at the study suture line must be maintained. Participants were considered treatment failures if they met any of the following conditions: * Did not achieve hemostasis at 4 minutes * Required additional hemostatic treatment during the first 4 minutes of the observation period * Experienced rebleeding after the first 4 minutes of the observation period.
90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line	4 minutes post start of treatment application	Hemostasis at the study suture line must be maintained until closure of the surgical wound. Participants were considered treatment failures if they met any of the following conditions: * Did not achieve hemostasis at 4 minutes * Required additional hemostatic treatment other than study treatment during the first 4 minutes of the observation period * Experienced rebleeding after the first 4 minutes of the observation period.
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. 1. 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. 2. 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.
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 Achieving Hemostasis at 6 Minutes	6 minutes post start of treatment application start	Hemostasis at the study suture line must be maintained until closure of the surgical wound.
Percentage of Participants Achieving Hemostasis at 10 Minutes	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 the Study Suture Line	Intraoperative day 0	Intraoperative rebleeding at the study suture line after occurrence of hemostasis.
Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line	Postoperative through day 30 ± 5	Any rebleeding requiring surgical reexploration
Percentage of Participants With Any Transfusion Requirement	Intraoperative (day 0) through day 30 ± 5	Proportion of participants who required transfusions (i.e., red blood cell (RBC) concentrates, fresh frozen plasma (FFP), and platelets)
Percentage of Participants With Graft Occlusions	Day 0 (procedure day) through day 30 ± 5	Determined clinically and defined as absence of blood flow through the graft.
Percentage of Participants With Infections at the Surgical Site	Day 0 (procedure day) through day 30 ± 5
Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline	Within 14 days prior to date of surgery
Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure	Preoperative baseline 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	Preoperative baseline 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	Preoperative baseline through postoperative Day 14	Percent Change in Respiratory Rate Measured as: Preoperative Baseline - Intraoperative Day 0; 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