A Phase II Clinical Study to Evaluate the Efficacy and Safety of rhThrombin in Subjects Undergoing Arterial Bypass Surgery and AV Graft Formation for Hemodialysis

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dc.contributor.advisorRustin E. Reeves
dc.contributor.committeeMemberDella Weis
dc.contributor.committeeMemberDon Peska
dc.creatorPlascencia, Xochitl
dc.date.accessioned2019-08-22T20:12:16Z
dc.date.available2019-08-22T20:12:16Z
dc.date.issued2004-12-01
dc.date.submitted2014-05-30T08:00:05-07:00
dc.description.abstractThe Association of American Medical Colleges Task Force on Clinical Research defines clinical research as a component of medical and health research intended to produce knowledge essential for understanding human disease, preventing and treating illness, and promoting health (Friedman, 1998). A clinical trial is defined as a research study conducted in humans which is designed to answer specific questions using scientifically controlled conditions with specified methodologies and endpoints (Gallin, 2002). Clinical research trials are essential in determining whether or not a drug is safe and effective. There are four phases that investigational drugs go through before they are allowed to be out in the market. Before beginning phase I of a study, there is usually a pre-clinical research and development phase. During this time the initial synthesis of study drug is accomplished and animal testing takes place. Phase I is the initial introduction of an investigational new study drug into humans. Phase I is usually conducted in healthy individuals and the primary goal is to determine the safety profile of the drug. Phase II trials tend to evaluate safety and initial efficacy. Subjects enrolled in this phase tend to have the disease necessary for use of study drug. Phase III studies are conducted to gather additional information about the effectiveness and safety of the drug and to determine the overall benefit-risk relationship of the drug. Finally, phase IV studies are usually referred to as post-marketing studies. During this phase, additional safety information is identified and the drug’s safety during routine use is evaluated. Each phase can range from two to ten years depending on the complexity of the clinical trial (Gallin, 2002). A phase II, randomized, double blind study of the safety and efficacy of topical recombinant human thrombin in patients undergoing peripheral arterial bypass surgery and arterio-venous graft formation for hemodialysis is the focus of the prospective drug study to be carried out in the surgery department at The University of North Texas Health Science Center. The primary objective of this study is to evaluate the safety and efficacy of recombinant human thrombin when used in different types of surgeries. Prior to signing an informed consent, subjects will have to meet inclusion and exclusion criteria set by study protocol. Study specific assessments and procedures will be performed after the informed consent is signed and dated. If bleeding at the anastomosis is found to necessitate intervention, a single application of either rhThrombin or placebo in combination with an absorbable hemostatic sponge to each anastomosis requiring hemostasis will be applied by the surgeon. The safety and efficacy of rhThrombin will be determined by measuring the incidence and severity of adverse events and of laboratory abnormalities. Occurrence of hemostasis within 600 seconds of application of the study drug at the anastomotic surgical site, incidence of anti-rhThrombin product antibodies, and time to hemostasis will also be measured.
dc.format.mimetypeapplication/pdf
dc.identifier.urihttps://hdl.handle.net/20.500.12503/28047
dc.language.isoen
dc.provenance.legacyDownloads0
dc.subjectCardiology
dc.subjectCardiovascular System
dc.subjectChemical and Pharmacologic Phenomena
dc.subjectChemicals and Drugs
dc.subjectClinical Epidemiology
dc.subjectHealth and Medical Administration
dc.subjectHealth Services Research
dc.subjectInvestigative Techniques
dc.subjectLife Sciences
dc.subjectMedical Pharmacology
dc.subjectMedicine and Health Sciences
dc.subjectOther Pharmacy and Pharmaceutical Sciences
dc.subjectPharmacy and Pharmaceutical Sciences
dc.subjectClinical research
dc.subjectdisease
dc.subjecthealth promotion
dc.subjectdrug safety
dc.subjectdrug efficacy
dc.subjectrhThrombin
dc.subjectanti-rhThrombin
dc.subjectphase 1 study
dc.subjectphase 2 study
dc.subjectphase 3 study
dc.subjectphase 4 study
dc.subjectinvestigational drugs
dc.subjectclinical trial
dc.subjectarterial bypass surgery
dc.subjectAV graft formation
dc.subjecthemodialysis
dc.subjectheart
dc.titleA Phase II Clinical Study to Evaluate the Efficacy and Safety of rhThrombin in Subjects Undergoing Arterial Bypass Surgery and AV Graft Formation for Hemodialysis
dc.typeProfessional Report
dc.type.materialtext
thesis.degree.departmentGraduate School of Biomedical Sciences
thesis.degree.disciplineClinical Research Management
thesis.degree.grantorUniversity of North Texas Health Science Center at Fort Worth
thesis.degree.nameMaster of Science

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