Study Stopped
No statistical differences on study endpoints between groups.
Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH)
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2008
CompletedFirst Posted
Study publicly available on registry
August 27, 2008
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
March 5, 2014
CompletedMarch 5, 2014
November 1, 2013
3.3 years
August 25, 2008
November 8, 2013
February 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Decreased Bleeding
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.
14 days
Study Arms (2)
Arm A
EXPERIMENTALArm A has FloSeal Matrix applied to EVH wound bed.
Arm B
NO INTERVENTIONArm B does not have FloSeal Matrix applied to EVH wound bed.
Interventions
10 ml of FloSeal Matrix will be applied to the endoscopic wound bed.
Eligibility Criteria
You may qualify if:
- Sign a consent form that has been approved by the Institutional Review Board.
- Be at least 18 years of age.
- Scheduled to undergo coronary artery bypass grafting with EVH.
- Be able to return to Duke University Medical Center for post-operative visit.
You may not qualify if:
- Be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Reported allergy to FloSeal Matrix™
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Baxter Healthcare Corporationcollaborator
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early
Results Point of Contact
- Title
- Terry Ainsworth, Director, Clinical Research Operations, Education & Training
- Organization
- Duke University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
James E Lowe, MD
Duke University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2008
First Posted
August 27, 2008
Study Start
June 1, 2009
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
March 5, 2014
Results First Posted
March 5, 2014
Record last verified: 2013-11