Blood Coagulation Clinical Trial
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
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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