Vascular Sealant Study - Full Text View

Sponsors and Collaborators:	Georgetown University Covidien
Information provided by:	Georgetown University
ClinicalTrials.gov Identifier:	NCT00618358

Purpose

Study Objective:To evaluate the safety and effectiveness of the Vascular Sealant compared with Gelfoam/Thrombin when used to seal bleeding anastomotic suture lines in patients undergoing vascular reconstructive surgery requiring placement of a PTFE graft (including extra-anatomic, infrainguinal bypass and arteriovenous (AV) access procedures).

Study Design: The study is a multi-center, prospective, randomized controlled clinical trial that will compare two methods for treating anastomotic leakage (bleeding). All subjects (n =151) will be randomized at a 3:1 ratio to receive either the investigational treatment (Vascular Sealant) or the control treatment (Gelfoam/Thrombin). Up to two (2) treatment sites may be evaluated for each subject. Subjects will be stratified by type of graft procedure: AV access graft or extra-anatomic and infra-inguinal graft. A minimum of 60 patients, and a maximum of 91 patients, will be enrolled in each stratum. Treatment randomization will be blocked by center and type of graft procedure (e.g., bypass or AV grafts). All subjects will undergo preoperative screening to determine eligibility and will be evaluated intraoperatively, at discharge or within 7 days of surgery, and 30 days post-procedure to monitor for hematologic disturbances, hemorrhagic events, wound complications and other potential acute post-operative adverse events.

Up to ten (10) investigational sites will participate in the study. Enrollment is expected to take approximately 8 months for an anticipated duration of the clinical investigation of approximately 9 to 10 months.

The primary objective of this trial is to demonstrate non-inferiority of the Vascular Sealant to Gelfoam/Thrombin when used to seal anastomotic suture lines in patients undergoing placement of PTFE vascular grafts (including extra-anatomic, infrainguinal bypass and arteriovenous access procedures).

Condition	Intervention	Phase
Arteriovenous Access Grafts or Extra-Anatomic and Infra-Inguinal Grafts	Device: Vascular Sealant System	Phase I

MedlinePlus related topics: Anatomy Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Official Title:	A Prospective, Randomized, Multi-Center, Two Arm Study to Evaluate the Safety and Effectiveness of the Vascular Sealant System Compared With Gelfoam/Thrombin for Control of Anastomosis Suture Line Bleeding in Patients Undergoing Vascular Reconstructive Surgery With PTFE Grafts

Further study details as provided by Georgetown University:

Study Start Date:

March 2007

Intervention Details:

The Vascular Sealant System is intended for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Preoperative Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for participation in the study:

> 18 years of age
Scheduled for elective vascular surgery that entails placement of a PTFE vascular graft including extra-anatomic, infrainguinal bypass and primary and secondary arteriovenous access procedures
Subject is willing and able to comply with all aspects of the treatment and evaluation schedule
Informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site

Preoperative Exclusion Criteria: Subjects who meet any of the following criteria are not eligible for participation in the study:

Subject has a known local or systemic infection
Subjects with known coagulapathies including hemophilia, factor deficiencies, platelet count < 80,000 u/mL, heparin induced thrombocytopenia or uncorrected INR > 1.5
Subject is participating in a clinical trial that requires treatment with another investigational device or drug
Subject is lactating or pregnant, or does not agree to use contraception for the duration of the study
Subject has a known hypersensitivity to any components of bovine thrombin preparations and/or material of bovine origin
The investigator determines that the subject should not be included in the study for reason(s) not already specified

Intraoperative Inclusion Criteria: Subjects must meet the following intraoperative inclusion criteria to be eligible for randomization:

Suture line leaks (bleeding) confirmed prior to randomization. Intraoperative Exclusion Criteria: Subjects who meet any of the following intraoperative exclusion criteria are considered screening failures and are not eligible to be randomized:
Incidental finding of any of the preoperative exclusion criteria
Subject has obvious contamination or a concurrent systemic infection
Investigator determines that participation in the study may jeopardize the safety or welfare of the subject

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618358

Contacts

Contact: Renee Laughlin, RN, MPH	202-444-7288	rxl4@gunet.georgetown.edu
Contact: Jill Steinkogler	202-444-6735

Locations

United States, District of Columbia
Georgetown University	Recruiting
3800 Reservoir Rd., NW, PHC Bld 3004A, District of Columbia, United States, 20007
Contact: Renee Laughlin, RN, MPH 202-444-7288 rxl@gunet.georgetown.edu
Principal Investigator: David Deaton, MD
Sub-Investigator: Richard Neville, MD

Sponsors and Collaborators

Georgetown University

Covidien

Investigators

Principal Investigator:

David Deaton, MD

Georgetown University

More Information

No publications provided

Study ID Numbers:	2007-072
Study First Received:	February 8, 2008
Last Updated:	February 19, 2008
ClinicalTrials.gov Identifier:	NCT00618358 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thrombin
Gelatin Sponge, Absorbable
Hemorrhage
Hemostatics

ClinicalTrials.gov processed this record on May 07, 2009