ACTIVE RESEARCH STUDIES IN THE DEPARTMENT OF SURGERY
ACTIVE CARDIOTHORACIC RESEARCH STUDIES
| PI |
CO-PI |
STUDY TITLE |
SPONSOR |
DATES |
| Ferraris, Victor |
|
Outcomes of Traumatic Injuries in Patients Receiving Warfarin Therapy |
Investigator-Initiated |
|
| Hoopes, Charles |
|
SynCardia Freedom Driver System Study |
SynCardia Systems Incorporated |
03/01/2012 – 02/28/2013 |
| Hoopes, Charles |
Bradley, Mark
Dampier, Connie
Ford, Stacy
Mullett, Timothy
Plunkett, Mark
Ramaiah, Chandrashekhar
Reda, Hassan |
Levitronix CentriMag VAS Failure to Wean from Cardiopulmonary Bypass Trial |
Thoratec Laboratories Co |
10/18/2011 – 03/31/2013 |
| Mullett, Timothy |
|
A Randomized, Multicenter, Open-Label, Phase III Study of Gemcitabine-Cisplatin Chemotherapy plus Necitumumab (IMB-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First Line Treatment of Patients with Stage IV Squamous Non-Small Cell Lung Cancer |
PPD Development Inc |
02/01/2011 – 01/31/2013 |
| Mullett, Timothy |
|
An International, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Luacnix Maintenance Therapy for Stages III/IV NSCLC Subjects Who Have Responded to or Have Stable Disease Following One Regimen of Front-line, Platinum-based Combination Chemotherapy |
NovaRX Corp |
05/01/2011 – 04/30/2013 |
| Mullett, Timothy |
|
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 ug Once Every 3 Weeks in Anemic Subjects with Advanced NSCLC Receiving Multi-cy... |
AMGen |
02/26/2010 – 12/31/2012 |
| Mullett, Timothy |
|
Spiration IBV Valve System-Humanitarian Use Device |
Investigator-Initiated |
|
| Plunkett, Mark |
|
Contegra Graft for Pediatric Congenital Heart Defect Repairs |
Investigator-Initiated |
|
| Ramaiah, Chandrashekhar |
|
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety and Tolerability of 20 mg/kg Dose of Ro4905417 Administered Every 4 Weeks for 32 Weeks in Patients Undergoing Coronary Artery Bypass Surgery (CABG) |
Hoffmann La Roche Inc |
05/10/2011 – 12/31/2013 |
| Ramaiah, Chandrashekhar |
|
A Randomized, Multicenter, Double-Blind, Group-Sequential Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine (V710) in Adult Patients Scheduled for Cardiothoracic Surgery |
Merck |
10/15/2008 – 12/31/2013 |
| Ramaiah, Chandrashekhar |
|
Effect of Antifibrinolytic Prophylaxis for On-pump Cardiac Surgery Transfusion Rates |
Investigator-Initiated |
|
| Ramaiah, Chandrashekhar |
|
A Comparison of Post-operative Thrombotic Complication for On-pump Versus Off-pump CABG |
Investigator-Initiated |
|
| Ramaiah, Chandrashekhar |
|
Study Assessing 20 mg/kg Dose of the Recombinant Human Monoclonal Antibody Against P-selectin in Patients Undergoing CABG Surgery |
Trialynx |
|
| Ramaiah, Chandrashekhar |
|
Randomized Phase II Proof of Concept Study of PMX-60056 in Comparison to Protamine in the Reversal of Heparin in Subjects Undergoing Primary CABG Surgery |
Polymedix |
|
| Reda, Hassan |
|
Evaluation of Perioperative Metoprolol Tartrate for Atrial Arrhythmis Prophylaxis in Patients Undergoing Non-cardiac Thoracic Surgery |
Investigator-Initiated |
|
| Saha, Sibu |
|
RHEOS Pivotal Trial |
CVRx |
09/04/2007 – 08/31/2012 |
| Saha, Sibu |
|
A Phase Two, Randomized, Open-label (with Blinded Plasminogen Activator and Placebo Control Group) Study to Evaluate the Effects of Different Intra-thrombus Infusion Regimens of Plasmin (Human) Compared to Plasminogen Activator and Placebo |
Talecris Biotherapeutics |
07/17/2011 – 05/31/2013 |
| Saha, Sibu |
|
An Open-Label, Randomized, Multicenter Phase IIIb Study to Access the Efficacy, Safety and Tolerance of Beriplex P/N Compared with Plasma for Rapid Reversal of Coagulopathy in Urgent/Emergency Surgery |
CSL Behring GmbH |
01/07/2010 – 12/31/2012 |
| Saha, Sibu |
|
Pneumenectomy for Lung Cancer and Outcome Analysis of 100 Consecutive Cases |
Investigator-Initiated |
|
| Saha, Sibu |
|
A Retrospective Review of Carotid Endarectomy in Cardiothoracic Surgery from 2002-2009 |
Investigator-Initiated |
|
| Saha, Sibu |
|
A Retrospective Review of Mediastinoscopy in Cardiothoracic Surgery from 2002-2007 |
Investigator-Initiated |
|
| Saha, Sibu |
|
A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism |
Pfizer |
10/25/2010 – 03/31/2012 |
| Saha, Sibu |
|
Study to Evaluate the Safety and Tolerability of Four Different Methods of Administering Plasmin in Patients with Acute Lower Extremity Native Artery or Bypass Graft Occlusion |
Talecris |
|
| Saha, Sibu |
|
Study to Assess the Clinical Safety and Efficacy of Intramuscular (IM) Injection of Allogeneic Placental Derived ASCs (PLX-PAD Cells) for the Treatment of Subjects with Critical Limb Ischemia (CLI) |
Pluristem |
|
| Saha, Sibu |
|
Effects of Dietary Watermelon Powder on Atherosclerosis and Hypertension in a Mouse Model |
Investigator-Initiated |
|
| Saha, Sibu
CO-PI:
Ferraris, Victor |
|
TachoSil — A Randomized, Open-Label, Parallel-Group, Multi-Center Trial to Compare Efficacy and Safety of TachoSil versus Surgical Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery |
Nycomed Amersham Inc. |
03/19/2012 – 02/28/2014 |
| Turner, Vicky |
|
Randomized, Prospective Evaluation of 2% Chlorhexidine Gluconate Cloths to Reduce Surgical Site Infection in Elective Cardiothoracic Surgery Patients |
University of Rochester |
04/01/2010 – 11/30/2012 |
| Wang, Dongfang |
|
SSTR: Development of Percutaneous DLC for Total Cava-Pulmonary Assistance |
NIH: W-Z Biotech LLC |
07/01/2011 – 05/31/2012 |
| Zwischenberger, Joseph |
|
Unliquidated Obligations: TLI Kentucky Center for Clinical and Translational Science |
National Center for Advancing Translational Sciences |
|
| Zwischenberger, Joseph |
|
Development of a Perfusion-Induced Systemic Hyperthermia Delivery Apparatus |
Exatherm LLC |
07/01/2011 – 06/30/2012 |
| Zwischenberger, Joseph |
|
SBIR: Novel Dense Hollow Fiber for Blood Gas Exchange |
Medarray Inc |
11/01/2011 – 06/30/2012 |
ACTIVE GENERAL SURGERY RESEARCH STUDIES
| PI |
STUDY TITLE |
SPONSOR |
DATES |
| Beck, Sandra |
Prospective Single Blinded Randomized Controlled Trial Comparing the Covidien EEA Hemorrhoid and Prolapse Stapling Set with DST Series Technology vs. Ethicon PPH03 in a Hemorrhoidopexy Procedure (HEMOSTASIS) |
Covidien |
08/20/2011 – 09/15/2012 |
| Bernard, Andrew |
A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients with Severe Sepsis |
Agennix Inc |
07/08/2011 – 06/30/2012 |
| Bernard, Andrew |
A Prospective Study Examining Clinical Outcomes Associated with the Management of the Open Abdomen with the AbThera Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique |
KCI USA Inc |
06/01/2010 – 05/31/2012 |
| Chang, Phillip |
Randomized, Multi-Center, Controlled Clinical Study on the Effect of S.A.F.E. Therapy on Disease Severity and Inflammation in Mechanically-Ventilated Subjects Due to Severe Sepsis |
SAFE bt Incorporated |
09/01/2010 – 12/31/2012 |
| Chang, Phillip |
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Anti-Inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS |
GlaxoSmithKline |
07/01/2009 – 06/30/2012 |
| Chang, Phillip |
A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter, Multinational Study to Compare the Safety and Efficacy of Amikacin Pulmonary Delivery System with SOC in Intubated and Mechanically-Ventilated Patients with Gram... |
Bayer Pharmaceuticals |
10/01/2008 – 08/31/2013 |
| Chang, Phillip |
A Prospective Evaluation of ABRA Abdominal Wall Closure System in Combination with VAC Therapy Compared to VAC Therapy Alone in the Management of Open Abdomen |
Canica Design Inc |
10/01/2008 – 09/30/2012 |
| Endean, Eric |
Jane Keeple Resident Educational Fund |
BlueGrass Community Foundation |
05/01/2011 – 04/30/2012 |
| Roth, John |
Feasibilitiy Study of the Use of Permacol Surgical Implant in the Closure of Abdominal Wall Defects after Removal of Infected Prosthetic Mesh |
Covidien |
01/01/2009 – 07/31/2012 |
| Roth, John |
A Single-Arm, Multi-Center, Retrospective Study with Prospective Follow-up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft |
Davol Inc Specialty Access Products |
05/19/2010 – 07/31/2012 |
| Roth, John |
Feasibility Study of the Use of Flex HD Surgical Implant in the Closure of Abdominal Wall Defects with Component Separation in Clean or Contaminated Cases |
Musculoskeletal Transplant Foundation |
11/01/2010 – 06/30/2012 |
| Roth, John |
MMDI Rebound Hernia Repair Device (HRD) |
Minnesota Medical Development Inc |
09/21/2009 – 08/31/2012 |
| Roth, John |
Davol Fellowship |
Davol Speciality |
01/01/2011 – 06/20/2012 |
| Roth, John |
Foundation for Surgical Fellowships 2011 – 2012 |
Foundation for Surgical Fellowships |
07/01/2011 – 06/30/2012 |
| Saito, Hiroshi |
The Role of Adipose Tissue in Age-dependent Sensitivity to Critical Illiness |
National Institute on Aging (NIA) |
08/01/2011 – 07/31/2016 |
| Saito, Hiroshi |
Vulnerability to Sepsis in Old Age |
National Institute on Aging (NIA) |
05/15/2005 – 04/30/2012 |
ACTIVE PLASTIC SURGERY RESEARCH STUDIES
ACTIVE TRANSPLANTATION RESEARCH STUDIES
| PI |
CO-PI |
STUDY TITLE |
SPONSOR |
DATES |
| Gedaly, Roberto |
|
Switching Study of Kidney Transplant Patients with Tremor to LCP-Tacro (STRATO) |
United Biosource Corp |
04/10/2012 – 01/31/2015 |
| Gedaly, Roberto |
|
A Randomized, Placebo Controlled, Double-Blind Comparative Study Evaluating the Effect of Ramipril on Urinary Protein Excretion in Maintenance Renal Transplant Patients Converted to Sirolimus |
Wyeth Pharmaceuticals Inc |
02/08/2008 – 07/31/2012 |
| Gedaly, Roberto |
|
A Faciliated Access Program to Provide Everlimus (RAD) for Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation |
Novartis |
10/12/2007 – 12/31/2012 |
| Gedaly, Roberto |
|
A 24 Month, Multi-Center, Open-Label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Concentration-Controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de novo Liver Transplant Recipients |
Novartis |
07/01/2008 – 10/15/2012 |
| Gedaly, Roberto |
|
Planned Transition to Sirolimus-Based Therapy vs. Continued Tacrolimus-Based Therapy in Renal Allograft Recipients |
Wyeth Pharmaceuticals Inc |
10/08/2009 – 09/30/2012 |
| Malluche, Martmut (Int Med – Nephrology) |
Gedaly, Roberto |
Effects of Zortress® + Tacrolimus (Everolimua) versus Standard Immunosuppression Therapy on Progression of Coronary Artery Calcifications in Patients with Renal Transplantation |
Novartis |
12/16/2012 – 12/31/2013 |
| Waid, Thomas |
|
A Two Part, Phase 1/2, Safety, PK and PD Study of TOL 101, an Anti-TCR Monoclonal Antibody for Prophylaxsis of Acute Organ Rejection in Patients Receiving Renal Transplantation |
Tolera Therapeutics Incorporated |
12/09/2010 – 12/31/2015 |
ACTIVE UROLOGY RESEARCH STUDIES
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