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Sponsored by: |
King Pharmaceuticals |
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Information provided by: | King Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00775398 |
The purpose of this study is to assess the effect of possible exposure to THROMBIN JMI® on activated partial thromboplastin time (aPTT) at 48 hours post surgery in subjects with likelihood of prior exposure to THROMBIN JMI® within the past 4 years.
Condition |
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Blood Coagulation |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Phase 4, Multicenter, Open-Label, Observational Study Assessing the Impact of Exposure to THROMBIN-JMI® (Thrombin, Topical U.S.P [Bovine Origin]) on Coagulation Parameters |
Whole blood
Estimated Enrollment: | 610 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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A
Subjects with anti-topical bovine thrombin antibodies pre-surgery, who received topical THROMBIN-JMI® during the study surgery.
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B
Subjects with anti-topical bovine thrombin antibodies pre-surgery, who did not received THROMBIN-JMI® during the study surgery.
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C
Subjects with no anti-topical bovine thrombin antibodies pre-surgery and who did receive THROMBIN-JMI® during the study surgery.
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D
Subjects with no anti-topical bovine thrombin antibodies pre-surgery and who did not receive THROMBIN-JMI® during the study surgery.
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This study is intended to observe the effects of possible repeat exposure to topical THROMBIN-JMI® on aPTT. Adult men and women who are scheduled to undergo qualified surgeries (defined as surgeries likely to require the use of an active topical hemostatic agent, but not likely to require transfusion of plasma), and who complete the informed consent process, and who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for the study. As an observational study any decisions regarding the necessity for treatment to achieve hemostasis with this hemostatic product as an aid for perioperative hemostasis will be determined by the surgeon based upon the individual subject's condition.
Consequently, several assumptions and estimations are made in the design of the study. It is assumed that 20% of enrolled subjects will have pre-surgery bovine thrombin antibodies, and that 60% will receive THROMBIN JMI® during the study surgery, resulting in approximately 75 subjects in the primary study cohort and 195 subjects in the primary reference cohort. The primary endpoint of aPTT is chosen as prolongation beyond the normal reference range indicates either a factor deficiency or presence of an inhibitor. The latter is identified by either no correction or partial correction during mixing studies. At 48 hours post potential secondary exposure the secondary immune response should be sufficiently mounted as to see any impact of neutralizing antibodies on the aPTT.
After completion of the study surgeries, subjects will be categorized into cohorts based on whether their pre-surgery plasmas had or did not have anti-topical bovine thrombin antibodies and whether the subject received or did not receive THROMBIN JMI® intraoperatively. The primary study cohort will be subjects with anti-topical bovine thrombin antibodies pre-surgery, who received THROMBIN JMI® during the study surgery. The primary reference cohort will be those subjects with no anti-topical bovine thrombin antibodies pre-surgery and who did not receive THROMBIN JMI® during the study surgery. Antibody assessments will be not be performed until the end of the study for all subjects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Adult men and women who are scheduled to undergo qualified surgeries that are likely to require the use of an active topical hemostatic agent.
Inclusion Criteria:
To be eligible for this study, a subject MUST meet the following inclusion criteria:
Exclusion Criteria:
To be eligible for this study, a subject MUST NOT meet any of the following exclusion criteria:
Contact: Leslie Jones | 512-450-6179 |
Study Director: | Craig A. Paterson, MD, MBA | Medical Affairs |
Responsible Party: | King Pharmaceuticals, Inc. ( Linda Wase, MD/ Executive Vice President Medical Affairs ) |
Study ID Numbers: | K847-08-4003 |
Study First Received: | October 16, 2008 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00775398 |
Health Authority: | United States: Institutional Review Board |
Hemostasis Thrombin-JMI Thrombin Blood Coagulation |
Thrombin |
Coagulants Therapeutic Uses Hematologic Agents Pharmacologic Actions Hemostatics |