Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Vascular Solutions, Inc King Pharmaceuticals |
---|---|
Information provided by: | Vascular Solutions, Inc |
ClinicalTrials.gov Identifier: | NCT00652314 |
This trial is designed as a prospective, multi-center, randomized, feasibility clinical trial to evaluate the safety and efficacy of Thrombi-Gel as an absorbable surgical hemostat.
Within this clinical evaluation, Thrombi-Gel will be compared to the current standard of care, a gelatin sponge (Gelfoam) plus Thrombin JMI, by using a 2:1 randomization ratio. Subjects will be randomized to one of two (2) treatment groups. One (1) group will be treated with Thrombi-Gel, while one (1) group will be treated with the gelatin sponge plus thrombin. All study data will be analyzed according to the subjects' assigned randomization group assignment, regardless of the treatment actually delivered.
Condition | Intervention | Phase |
---|---|---|
Surgical Intervention Hemostasis Comparison of Surgical Hemostats |
Device: Thrombi-Gel |
Phase IV |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin |
Estimated Enrollment: | 75 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Thrombi-gel treatment
|
Device: Thrombi-Gel
Applicaton of Hemostatic product during surgery
|
2: Active Comparator
Gelatin Sponge (Gelfoam) plus thrombin
|
Device: Thrombi-Gel
Applicaton of Hemostatic product during surgery
|
This is a prospective, randomized, multi-center investigation with a minimum of seventy five (75) study subjects designed to evaluate the safety and effectiveness of the Thrombi-Gel product as an absorbable hemostat in the surgical patient population.
Subjects who are undergoing orthopedic/spinal, general, cardiac, hepatic or vascular surgical procedures should be considered for this investigation. Subjects can be pre-screened utilizing standard of care data for the specified inclusion/exclusion criteria to ensure that they are eligible for treatment in the investigation. If the subject appears to qualify for the investigation, the subject will then be asked to give his/her written informed consent. If, during surgery, the surgeon encounters a bleeding site that he or she is unable or unwilling to easily control due to failure or impracticality of conventional methods (sutures and/or cautery), the subject may be enrolled and randomized to receive either the investigational or control treatment. If the subject has multiple bleeding sites, each site to a maximum of 5 sites, may be treated with the assigned surgical hemostat. However, only the first site treated will be used to determine study objectives. All subjects will be followed through their hospitalization.
A follow-up evaluation will be conducted at approximately 30 and 60 days post-procedure to determine the long-term effectiveness of the hemostatic treatment received, incidence of late adverse events, and interim immunologic response to the study treatment device. Follow-up evaluations will include obtaining a blood specimen that evaluates for antibody development, coagulation, and Factor Va testing. Blood samples will be sent to independent labs for analysis.
From baseline to the final study exam, data pertaining to the investigational objectives will be recorded on the appropriate case report forms at the predetermined study intervals. The investigation will be conducted at a minimum of five (5) sites, but no more than fifteen (15) sites.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion criteria to be determined during the surgical procedure:
1. The subject has an intraoperative bleeding site which the surgeon is unable or unwilling to easily control with conventional methods (cautery, sutures)
Exclusion Criteria:
Contact: Robyn Schacherer | 763-656-4267 | rschacherer@vascularsolutions.com |
Contact: Deborah Neymark | 763-656-4349 | DNeymark@vascularsolutions.com |
United States, Illinois | |
Southern Illinois University School of Medicine | Recruiting |
Springfield, Illinois, United States, 66702 | |
Contact: Carol Buettner 217-545-2320 | |
Principal Investigator: Colleen M Johnson, MD | |
United States, Michigan | |
Michigan Vascular Research Center | Recruiting |
Flint, Michigan, United States, 48507 | |
Contact: Brenda Buckle 810-600-2009 | |
Principal Investigator: Carlo Dall' Omo, MD | |
United States, Texas | |
Texas Tech University Health Sciences Center | Recruiting |
Lubbock, Texas, United States, 79415 | |
Contact: Chris Scott-Johnson 806-743-4222 ext 312 | |
Contact: Ruth Guard 806-743-4222 ext 313 | |
Principal Investigator: Timothy M Risko, MD |
Responsible Party: | Vascular Solutions Inc. ( Deborah Neymark ) |
Study ID Numbers: | 0307, The CONTROL Study |
Study First Received: | March 28, 2008 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00652314 |
Health Authority: | United States: Food and Drug Administration |
Hemostatic products Surgical hemostasis Thrombi-gel Gelatin Sponge Time to hemostasis |
Thrombin Embolism and Thrombosis Embolism |
Vascular Diseases Gelatin Sponge, Absorbable Thrombosis |
Coagulants Therapeutic Uses Hematologic Agents |
Cardiovascular Diseases Pharmacologic Actions Hemostatics |