Clinical trial NCT00892957: FS VH S/D 500 S-apr in Vascular Surgery
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: PHASE3
Conditions: Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses
Keywords: Vascular Surgery
Arterio-arterial bypasses
Arterio-venous (AV) shunts
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2009-05-05
Enrollment: 176
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 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.
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 Who Achieved Hemostasis at 6 Minutes Post Treatment Application
timeFrame: 6 minutes post start of treatment application
measure: Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application
timeFrame: 10 minutes post start of treatment application
measure: Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line
timeFrame: Intraoperative day 0
measure: Percentage of Participants With Postoperative Rebleeding
timeFrame: Postoperative through day 30 ± 5
measure: Percentage of Participants With Graft Occlusion
timeFrame: post-op discharge/day 1, post-op day 14 and day 30
measure: Percentage of Participants With Infection at the Surgical Site
timeFrame: post-op discharge/day 1, post-op day 14 and day 30
measure: Number of Participants With Infections by Grade
timeFrame: post-op discharge/day 1, post-op day 14 and day 30
measure: Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline
timeFrame: Within 14 days prior to date of surgery
measure: Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure
timeFrame: Within 14 days prior to surgery 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: Within 14 days prior to surgery 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: Within 14 days prior to surgery 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: Fresno
country: United States
state: California
city: Orange
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Jacksonville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Fort Wayne
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Saginaw
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Hackensack
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: Dayton
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Baxter Innovations GmbH
name: Isabella Presch, MD, MBA
role: STUDY_DIRECTOR
References:
citation: Saha SP, Muluk S, Schenk W 3rd, Dennis JW, Ploder B, Grigorian A, Presch I, Goppelt A. A prospective randomized study comparing fibrin sealant to manual compression for the treatment of anastomotic suture-hole bleeding in expanded polytetrafluoroethylene grafts. J Vasc Surg. 2012 Jul;56(1):134-41. doi: 10.1016/j.jvs.2012.01.009. Epub 2012 May 25.