Clinical trial NCT00576420: Fibrin Sealant Vascular Surgery Study
Official title: Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 S-apr for Hemostasis in Subjects Undergoing Vascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.
timeFrame: 4 minutes post start of treatment application
measure: 90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line
timeFrame: 4 minutes post start of treatment application
measure: Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding
timeFrame: 4 minutes post start of treatment application
measure: Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding
timeFrame: 4 minutes post start of treatment application
Secondary outcomes:
measure: Percentage of Participants Achieving Hemostasis at 6 Minutes
timeFrame: 6 minutes post start of treatment application start
measure: Percentage of Participants Achieving Hemostasis at 10 Minutes
timeFrame: 10 minutes post start of treatment application
measure: Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line
timeFrame: Intraoperative day 0
measure: Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line
timeFrame: Postoperative through day 30 ± 5
measure: Percentage of Participants With Any Transfusion Requirement
timeFrame: Intraoperative (day 0) through day 30 ± 5
measure: Percentage of Participants With Graft Occlusions
timeFrame: Day 0 (procedure day) through day 30 ± 5
measure: Percentage of Participants With Infections at the Surgical Site
timeFrame: Day 0 (procedure day) through day 30 ± 5
measure: Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline
timeFrame: Within 14 days prior to date of surgery
measure: Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure
timeFrame: Preoperative baseline through postoperative Day 14
measure: Vital Signs: Heart Rate - Preoperative Baseline
timeFrame: Within 14 days prior to date of surgery
measure: Percent Change in Vital Signs: Heart Rate
timeFrame: Preoperative baseline through postoperative Day 14
measure: Vital Signs: Respiratory Rate - Preoperative Baseline
timeFrame: Within 14 days prior to date of surgery
measure: Percent Change in Vital Signs: Respiratory Rate
timeFrame: Preoperative baseline through postoperative Day 14
measure: Laboratory Values Over Time: Hemoglobin
timeFrame: Preoperative baseline through postoperative Day 14
measure: Laboratory Values Over Time: Hematocrit
timeFrame: Preoperative baseline through postoperative Day 14
measure: Laboratory Values Over Time: Erythrocytes
timeFrame: Preoperative baseline through postoperative Day 14
measure: Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes
timeFrame: Preoperative baseline through postoperative Day 14
measure: Laboratory Values Over Time: Platelets
timeFrame: Preoperative baseline through postoperative Day 14
measure: Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)
timeFrame: Preoperative baseline through postoperative Day 14
measure: Laboratory Values Over Time: Alanine Aminotransferase (ALT)
timeFrame: Preoperative baseline through postoperative Day 14
measure: Laboratory Values Over Time: Aspartate Aminotransferase (AST)
timeFrame: Preoperative baseline through postoperative Day 14
measure: Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)
timeFrame: Preoperative baseline through postoperative Day 14
measure: Laboratory Values Over Time: International Normalized Ratio (INR)
timeFrame: Preoperative baseline through postoperative Day 14
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Long Beach
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Lexington
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Pittsburgh
country: United States
state: Pennsylvania
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
References:
citation: Saha SP, Muluk S, Schenk W 3rd, Burks SG, Grigorian A, Ploder B, Presch I, Pavlova BG, Hantak E. Use of fibrin sealant as a hemostatic agent in expanded polytetrafluoroethylene graft placement surgery. Ann Vasc Surg. 2011 Aug;25(6):813-22. doi: 10.1016/j.avsg.2010.12.016. Epub 2011 Apr 21.