Cardiac Surgery Requiring Cardiopulmonary Bypass and Median SternotomyPhase 3NCT00161733
Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery
A Phase 3 study testing Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) and TISSEEL VH fibrin sealant in people with Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy and Cardiopulmonary Bypass, run by Baxter Healthcare Corporation at 22 sites in United States.
Trial summary
The objective of this study is to demonstrate equivalent hemostatic efficacy and safety between FS VH S/D and TISSEEL VH fibrin sealant in subjects undergoing cardiac surgery requiring cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy, Cardiopulmonary Bypass, Sternotomy
- What is being tested?
- Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) and TISSEEL VH fibrin sealant
- How many people
- Not given
- Where
- 22 sitesUnited States
- Study dates
- Sep 2002to Nov 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- All subjects accepted for this study must be:
- Informed of the nature of the study and have provided written informed consent
- >= 18 years of age
- Scheduled to undergo cardiac surgery requiring CPB and median sternotomy
- Able and willing to comply with the procedures required by the protocol.
- Additional Intraoperative Eligibility Criteria (in addition to the above):
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- Subjects must satisfy the following intraoperative criteria in order to be eligible for treatment with either investigational product:
- Subjects must complete all screening/preoperative evaluations (see study protocol)
- Subjects must present, after cessation of cardiopulmonary bypass and heparin reversal by protamine sulfate, with a minimum of one intraoperative bleeding site which cannot be controlled by conventional surgical techniques (i.e., suture, ligature, cautery, clips, and clamps) alone and which has not been previously treated with any topical hemostatic agent
- Subjects must not have received any commercial or blood bank-derived fibrin sealant prior to application of investigational product.
Who cannot join
- Any one or more of the following are cause for exclusion from the study:
- Subject is scheduled to undergo a cardiac surgical procedure which does not require CPB and median sternotomy (e.g., thoracotomy, minimally invasive direct coronary artery bypass, etc.)
- Subject has undergone a sternotomy within 36 hours prior to being randomized under this protocol
- History of any hereditary or acquired bleeding disorders. Subjects concurrently treated with prophylactic antithrombotic therapy (i.e., aspirin, heparin, Warfarin, etc.) are eligible
- Either of the following: International Normalized Ratio (INR) >1.35, activated or partial thromboplastin time (aPTT) greater than 35 seconds in subjects who are not on antithrombotic therapy (i.e., aspirin, heparin, Warfarin, etc.)
- Fibrinogen level less than 150mg/dL
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- Platelet count less than 100,000/mm3
- Active hepatic disease (persistent alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels greater than 2.5X the upper limit of normal)
- Subject was previously randomized under this protocol
- Pregnancy or lactation
- Known sensitivity to aprotinin or bovine protein
- Subject is currently participating in another clinical study and has received an investigational product or device within 30 days prior to study entry
- Treatment with thrombolytic agents (e.g. tissue plasminogen activator [tPA], Streptase® [streptokinase], Activase® [alteplase], Retavase® [reteplase],) Integrilin® (eptifibatide), Aggrastat® (tirofiban), Plavix® (clopidogrel), ReoPro® (abciximab), or Ticlid® (ticlopidine), Pletal® (cilostazol) < 24 hours prior to treatment with investigative product
- Subject is scheduled for heart transplantation
- Subject is scheduled for left ventricular assist device insertion or removal
- Subject is scheduled to undergo any surgical procedure other than the cardiac surgery for which the subject is being treated under this protocol within 14 days prior to treatment. Surgeries in the pericardium associated with the cardiac surgery and not specifically excluded above are permitted.
- Subject has an anticipated life expectancy of <=6 months.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109-0344
Peachtree Cardiovascular
Atlanta, Georgia, 30342
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215-5501
UMDNJ - Robert Wood Johnson Medical School
Camden, New Jersey, 08103
University of Virginia Health System
Charlottesville, Virginia, 22908
University of Chicago Medical Center
Chicago, Illinois, 60637
The Linder Clinical Trial Center
Cincinnati, Ohio, 45219
The Cleveland Clinic
Cleveland, Ohio, 44195
Baylor University Medical Center
Dallas, Texas, 75246
Duke University Medical Center
Durham, North Carolina, 27710
Shands Hospital at the University of Florida
Gainesville, Florida, 32610-0286
University of Kentucky Medical Center
Lexington, Kentucky, 40536-0293
Brevard Cardio Surgeons/Health First Heart Institute
Melbourne, Florida, 32901
Lenox Hill Hospital
New York, New York, 10021
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
UCI Medical Center
Orange, California, 92868-3298
Banner Health Research Institute
Phoenix, Arizona, 85006
The Oregon Clinic
Portland, Oregon, 97213
St. Joseph's/Candler Health System, Inc.
Savannah, Georgia, 31405
Cardiac Surgery Service, Baystate Medical Center
Springfield, Massachusetts, 01199
Washington University Medical Center
St Louis, Missouri, 63110
Franciscan Health System Research Center
Tacoma, Washington, 98405
About this study
Official title: Evaluation of the Topical Hemostatic Efficacy and Safety of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery
The objective of this study is to demonstrate equivalent hemostatic efficacy and safety between FS VH S/D and TISSEEL VH fibrin sealant in subjects undergoing cardiac surgery requiring cardiopulmonary bypass. If bleeding is still present after conventional surgical methods to achieve hemostasis have been applied FS VH S/D or Tisseel VH are applied. Achievement of hemostasis within 5 minutes is compared between the study groups.
- Conditions
- Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy, Cardiopulmonary Bypass, Sternotomy
- Being tested
- Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D), TISSEEL VH fibrin sealant
- Keywords
- Cardiopulmonary bypass, Median sternotomy, Fibrin sealant, Clot, Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D)Drug
TISSEEL VH fibrin sealantDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startSep 2002
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery Requiring Cardiopulmonary Bypass and Median SternotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeffrey Milliken, MD, Principal investigator, UCI Medical Center, Orange, CAJohn Rousou, MD, Principal investigator, Baystate Medical Center, Springfield, MACharles Klodell, MD, Principal investigator, Shads Hospital at the University of Florida, Gainesville, FLRussell Vester, MD, Principal investigator, The Linder Clinical Trial Center, Cincinnati, OHNicholas Smedira, MD, Principal investigator, The Cleveland Clinic, Cleveland, OHSteven Bolling, MD, Principal investigator, University of Michigan Hospital, Ann Arbor, MISidney Levitsky, MD, Principal investigator, Beth Israel Deaconess Medical CenterJames Lowe, MD, Principal investigator, Duke University Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161733
- Sponsor's protocol ID
- 550003
- Status last verified
- Apr 2017
- First submitted
- 8 Sep 2005
- Last updated
- 5 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Topical Hemostatic Efficacy and Safety of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00161733
- Acronym / sponsor ID
- 550003
- Conditions
- Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy, Cardiopulmonary Bypass, Sternotomy
- Keywords
- Cardiopulmonary bypass, Median sternotomy, Fibrin sealant, Clot, Cardiac surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Study completion
- Nov 2004
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to demonstrate equivalent hemostatic efficacy and safety between FS VH S/D and TISSEEL VH fibrin sealant in subjects undergoing cardiac surgery requiring cardiopulmonary bypass. If bleeding is still present after conventional surgical methods to achieve hemostasis have been applied FS VH S/D or Tisseel VH are applied. Achievement of hemostasis within 5 minutes is compared between the study groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed of the nature of the study and have provided written informed consent
- >= 18 years of age
- Scheduled to undergo cardiac surgery requiring CPB and median sternotomy
- Able and willing to comply with the procedures required by the protocol.
- Subjects must satisfy the following intraoperative criteria in order to be eligible for treatment with either investigational product:
Key exclusion criteria (17 listed)
- Subject is scheduled to undergo a cardiac surgical procedure which does not require CPB and median sternotomy (e.g., thoracotomy, minimally invasive direct coronary artery bypass, etc.)
- Subject has undergone a sternotomy within 36 hours prior to being randomized under this protocol
- History of any hereditary or acquired bleeding disorders. Subjects concurrently treated with prophylactic antithrombotic therapy (i.e., aspirin, heparin, Warfarin, etc.) are eligible
- Either of the following: International Normalized Ratio (INR) >1.35, activated or partial thromboplastin time (aPTT) greater than 35 seconds in subjects who are not on antithrombotic therapy (i.e., aspirin, heparin, Warfarin, etc.)
- Fibrinogen level less than 150mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) | Drug | – |
| TISSEEL VH fibrin sealant | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Milliken, MD principal investigator
UCI Medical Center, Orange, CA
John Rousou, MD principal investigator
Baystate Medical Center, Springfield, MA
Charles Klodell, MD principal investigator
Shads Hospital at the University of Florida, Gainesville, FL
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) and TISSEEL VH fibrin sealant in people with Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy and Cardiopulmonary Bypass, run by Baxter Healthcare Corporation at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.