Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Baxter Healthcare Corporation |
---|---|
Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00576420 |
The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) for hemostasis in subjects receiving prosthetic expanded polytetrafluoroethylene (ePTFE) conduits as compared to a control group treated by manual compression with surgical gauze pads.
Condition | Intervention | Phase |
---|---|---|
Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts) |
Drug: FS VH S/D 500 s-apr , 60 seconds polymerization time Drug: FS VH S/D 500 s-apr , 120 seconds polymerization time Procedure: Manual compression with surgical gauze pads |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 s-Apr for Hemostasis in Subjects Undergoing Vascular Surgery |
Estimated Enrollment: | 102 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time
|
Drug: FS VH S/D 500 s-apr , 60 seconds polymerization time
FS VH S/D 500 s-apr is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr.
|
2: Experimental
FS VH S/D 500 s-apr, 120 seconds polymerization time
|
Drug: FS VH S/D 500 s-apr , 120 seconds polymerization time
Treatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps.
|
3
Treatment of the study-suture line will be manual compression with surgical gauze pads.
|
Procedure: Manual compression with surgical gauze pads
Treatment of the study-suture line will be manual compression with surgical gauze pads.
|
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Intraoperative inclusion criterion:
- Suture line bleeding eligible for study treatment is present after surgical hemostasis (i.e., suturing).
Suture line bleeding eligible for study treatment is defined as: any suture line bleeding that would prevent immediate closure of the wound and require treatment of the bleeding first, and on a scale of mild, moderate, and severe, the suture line bleeding is assessed as moderate or severe. (Moderate is defined as: either more than 25% of the suture line bleeds, or at least 5 suture line bleedings are present, if counting of suture line bleedings is possible, or one pulsatile suture line bleeding is present. Severe is defined as: either more than 50% of the suture line bleeds, or at least 10 suture line bleedings present, if counting of suture line bleedings is possible, or more than one pulsatile suture line bleedings are present, or at least one spurting suture line bleeding is present.)
Note: Bleedings that can be treated with additional sutures are not appropriate for the study. Such anastomoses should receive additional sutures, be re-categorized, and if they still comply with the inclusion criteria, be randomized.
Exclusion Criteria:
Intraoperative exclusion criterion:
United States, Alabama | |
Cardio-Thoracic Surgeons, P.C. | |
Birmingham, Alabama, United States, 35235 | |
United States, Arizona | |
Arizona Endovascular Center | |
Tucson, Arizona, United States, 85710 | |
United States, California | |
VA San Diego Healthcare System | |
San Diego, California, United States, 92161 | |
Long Beach VA Healthcare System | |
Long Beach, California, United States, 90822 | |
United States, Florida | |
Baptist Medical Center, Jacksonville Center for Clinical Research | |
Jacksonville, Florida, United States, 32216 | |
Health First Clinical Research Institute | |
Melbourne, Florida, United States, 32901 | |
Memorial Hospital Jacksonville, Jacksonville Center for Clinical Research | |
Jacksonville, Florida, United States, 32216 | |
United States, Illinois | |
University of Chicago, Department of Surgery, J-555 | |
Chicago, Illinois, United States, 60637 | |
United States, Kentucky | |
University of Kentucky Department of Surgery, Division of Cardiovascular and Thoracic Surgery | |
Lexington, Kentucky, United States, 40536-0200 | |
United States, Louisiana | |
Vascular Surgery Associates of Baton Rouge, Clinical research Division | |
Baton Rouge, Louisiana, United States, 70809-3675 | |
United States, Pennsylvania | |
Allegheny General Hospital | |
Pittsburgh, Pennsylvania, United States, 15212 | |
United States, Utah | |
University of Utah Department of Surgery | |
Salt Lake City, Utah, United States, 84132 | |
United States, Virginia | |
Surgical Therapeutic Advancement Center, University of Virginia | |
Charlottesville, Virginia, United States, 22908 | |
Vascular and Transplant Specialists | |
Virginia Beach, Virginia, United States, 23452 | |
United States, Washington | |
Harbor View Medical Center | |
Seattle, Washington, United States, 98104 |
Responsible Party: | Baxter Healthcare Corporation ( Edward J. Kim, Clinical Project Manager ) |
Study ID Numbers: | 550602 |
Study First Received: | December 18, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00576420 |
Health Authority: | United States: Food and Drug Administration |
Fibrin Tissue Adhesive |