Clinical trial NCT00154141: Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures
Official title: A Prospective, Randomized Controlled Study to Compare the Effects of a Fibrin Sealant (FS2) Versus Manual Compression on Haemostatic Efficacy During Vascular Surgical Procedures Utilising Polytetrafluorethylene Graft Material on an End-to-Side Femoral or Upper Extremity Vascular Access Arterial Anastomosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Vascular Disease
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
Collaborators: name: OMRIX Biopharmaceuticals
First posted: 2005-09-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side femoral or upper extremity vascular access arterial anastomosis (e.g. femoral-femoral, femoral-popliteal, femoral-tibial, ilio-femoral, aorto-bifemoral, abdominal aortic aneurysm, upper extremity vascular access for dialysis) using uncoated or heparin-coated PTFE grafts and polypropylene sutures (size 5-0 or 6-0) with a 1:1 needle-to-thread ratio.
* Following initial arterial clamp release, the study surgeon determines that adjunctive measures are needed to obtain haemostasis at the SAS.
* Subjects must be willing to and capable of participating in the study, and provided written informed consent.

Exclusion Criteria:

* Subjects undergoing re-vascularisation using autologous conduits (e.g. saphenous vein) or prosthetic material other than uncoated or heparin-coated PTFE.
* Subjects undergoing emergency surgery.
* Subjects with any intra-operative findings that may preclude conduct of the study procedure.
* Subjects with known intolerance to heparin, blood products or to one of the components of the study product.
* Subjects unwilling to receive blood products.
* Subjects with autoimmune immunodeficiency diseases (including known HIV).
* Subjects who are known, current alcohol and / or drug abusers.
* Subjects who have participated in another investigational drug or device research study within 30 days of enrolment.
* Female subjects who are pregnant or nursing.

Primary outcomes:
measure: Attainment of hemostasis at following randomization.
Secondary outcomes:
measure: Attainment of hemostasis following randomization.
measure: Incidence of treatment failures
measure: Incidence of potential bleeding-related complications
measure: Adverse events
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Memorial Hospital
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Worcester
country: United States
facility: Univ of Mass Medical Center
state: Massachusetts
city: Hackensack
country: United States
facility: Hackensack Medical Center
state: New Jersey
city: Albany
country: United States
facility: Alband Medical Center
state: New York
city: Buffalo
country: United States
facility: Millarad Fillmore Hospital, SUNY
state: New York
city: Toledo
country: United States
facility: Jobst Vascular Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt Univ Medical Center
state: Tennessee
city: Charlottesville
country: United States
facility: UVA Health System
state: Virginia
city: Norfolk
country: United States
facility: Vascular and Transplant Specialists
state: Virginia
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
Study officials:
References:
citation: Chalmers RT, Darling Iii RC, Wingard JT, Chetter I, Cutler B, Kern JA, Hart JC. Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures. Br J Surg. 2010 Dec;97(12):1784-9. doi: 10.1002/bjs.7235. Epub 2010 Aug 20.