Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH)

This study has been terminated.
(No statistical differences on study endpoints between groups.)
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00742313
First received: August 25, 2008
Last updated: February 17, 2014
Last verified: November 2013
  Purpose

This is a prospective, randomized trial to see in patients undergoing coronary artery bypass grafting and endoscopically-harvested greater saphenous vein, if using FloSeal Matrix in the endoscopically-harvested saphenous vein wound bed decreases bleeding and complications.


Condition Intervention Phase
Bleeding
Biological: FloSeal Matrix
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Number of Participants With Decreased Bleeding [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    The number of participants with less than expected bleeding (bleeding typically expected for the vein grafting procedure) at the surgical site. Blood was collected in the Blake drain of the EVH wound bed treated with FloSeal MatrixFloSeal Matrix™in the tunnel of the endoscopically harvested Greater Saphenous vein.


Enrollment: 50
Study Start Date: June 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Arm A has FloSeal Matrix applied to EVH wound bed.
Biological: FloSeal Matrix
10 ml of FloSeal Matrix will be applied to the endoscopic wound bed.
Other Name: FloSeal Hemostatic Matrix
No Intervention: Arm B
Arm B does not have FloSeal Matrix applied to EVH wound bed.

Detailed Description:

Purpose of Study: The primary objective of this study is to determine if using a hemostatic agent (FloSeal Matrix™) in the tunnel of the endoscopically harvested Greater Saphenous vein will decrease bleeding from that site. Secondary objectives are to determine if there is a decrease in the infection-rate at the site of the vein-harvested leg where the FloSeal Matrix™ was used compared to the ones where FloSeal Matrix™ was not used.

Background and Significance: FloSeal Matrix™ is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. It works on wet, actively bleeding tissue and conforms to irregular wound surfaces. It is proven to control bleeding from oozing to pulsatile flow. The EVH wound bed is irregular and hemostasis is, at times, difficult to obtain using conventional procedures such as ligature or cautery.

Design and Procedures: This is a prospective, randomized clinical trial that compares the effects of applying FloSeal Matrix™ to the EVH wound bed to not applying FloSeal Matrix™ to the EVH wound bed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sign a consent form that has been approved by the Institutional Review Board.
  2. Be at least 18 years of age.
  3. Scheduled to undergo coronary artery bypass grafting with EVH.
  4. Be able to return to Duke University Medical Center for post-operative visit.

Exclusion Criteria:

  1. Be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study.
  2. Reported allergy to FloSeal Matrix™
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742313

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Baxter Healthcare Corporation
Investigators
Principal Investigator: James E Lowe, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00742313     History of Changes
Other Study ID Numbers: Pro00009897
Study First Received: August 25, 2008
Results First Received: November 8, 2013
Last Updated: February 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Endoscopic
saphenous
vein
harvest

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014