UW Clinical Trials Center
The UW Clinical Trials Center (UW CTC) provides key leadership, infrastructure, and statistical project support to both complex and pragmatic multi-center clinical trials. Our expertise includes scientific study design, adaptive clinical trial management systems, regulatory knowledge, and overall project leadership.
The UW Clinical Trials Center is an established team of biostatisticians, programmers, and project management staff that have extensive experience designing, planning, implementing, conducting, and monitoring large-scale clinical trials. They bring to the table a broad set of skills, and have an established foundation built on open communication and active collaborative problem solving that has ensured the success of many complex clinical trials.
The center is a critical resource for investigators at the UW and nation-wide who are striving to improve clinical approaches in emergency medicine, cardiovascular disease, and other areas.
For the past 10 years the UW CTC has been the home for the NHLBI sponsored Resuscitation Outcomes Consortium (ROC) a network that consists of 10 Regional Clinical Centers (RCCs), and a Data and Coordinating Center (DCC). ROC provides infrastructure to advance rapid translation of promising scientific and clinical interventions to improve patient outcomes.
We welcome new opportunities for collaboration; please reach out to us at: uwctc@uw.edu
Leadership
Susanne May, Principal Investigator for Resuscitation Outcomes Consortium (ROC)
Gerald van Belle, Principal Investigator (multiple PI with Susanne May) for PROPPR and PROHS Studies
Eileen Bulger, Co-Principal Investigator, Trauma
Scott Emerson, Principal Investigator A-TREAT
Graham Nichol, Co-Principal Investigator and ROC Medical Director
Brian Leroux, Faculty Statistician
Barbara McKnight, Faculty Statistician
Michelle Doyle, Project Director
Jonas Carson, Manager of Data Operations
Members
Ben Bergsten-Buret, Web Application Engineer
Siobhan Brown, Research Scientist
Heather Herren, Project Manager, Cardiac
Delores Kannas, Project Manager, Trauma
Noah Kime, Research Assistant
Winnie Kirdpoo, Web Application Engineer
Umberto Lenzi, Computer and Network Technician
Eric Meier, Research Scientist
Rob Schmicker, Research Scientist
Daniel Shea, Student Assistant
Meghann Seiler, Project Manager
Eshy Shahrazad, Research Coordinator
Ellen Terry, Publications Coordinator
Current UW CTC studies include:
A-TREAT – This study compares the incidences of bleeding and thrombosis and the transfusion requirements in patients randomized to receive TXA or a placebo for hypo-proliferative thrombocytopenia secondary to primary marrow disorders, chemotherapy, immunotherapy, radiation, and/or hematopoietic stem cell transplant.
ALPS – The primary aim of this study was to determine if survival to hospital discharge is improved with early therapeutic administration of a new formulation of IV amiodarone compared to placebo and lidocaine.
PART – This pragmatic trial compares the effectiveness of primary endotracheal intubation versus primary laryngeal tube airway management strategies upon 72-hour survival after out-of-hospital cardiac arrest.
TXA - This multi-center, Phase II trial is designed to determine if tranexamic acid initiated in the prehospital setting improves long-term neurologic outcome compared to placebo in patients with moderate to severe traumatic brain injury who are not in shock.
PROHS – This pragmatic, multicenter, prospective observational study compares the effectiveness of two different existing prehospital resuscitation approaches in severely injured trauma patients transported by air ambulance.
PCAAM – This prospective multicenter observational study seeks to improve understanding of current out-of-hospital pediatric airway management. Patients will be enrolled from participating EMS agencies when there is a treated out-of-hospital cardiac arrest in a patient less than 18 years old.
Epistry – The primary goal of this trial was to develop the rationale and methods for a standard, reliable, and valid epidemiologic databank of out-of-hospital cardiac arrest and life-threatening trauma cases with in-hospital outcomes after five years.
Highlighted Publications
Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest. Kudenchuk PJ, Brown SP, Daya M, Rea T, Nichol G, Morrison LJ, Leroux B, Vaillancourt C, Wittwer L, Callaway CW, Christenson J, Egan D, Ornato JP, Weisfeldt ML, Stiell IG, Idris AH, Aufderheide TP, Dunford JV, Colella MR, Vilke GM, Brienza AM, Desvigne-Nickens P, Gray PC, Gray R, Seals N, Straight R, Dorian P, and the ROC Investigators. New England Journal of Medicine 2016; 374:1711-1722 Link
Trial of continuous or interrupted chest compressions during CPR. Nichol G, Leroux B, Wang H, Callaway CW, Sopko G, Weisfeldt M, Stiell I, Morrison LJ, Aufderheide TP, Cheskes S, Christenson J, Kudenchuk P, Vaillancourt C, Rea TD, Idris AH, Colella R, Isaacs M, Straight R, Stephens S, Richardson J, Condle J, Schmicker RH, Egan D, May S, Ornato JP, and the ROC Investigators. New England Journal of Medicine 2015; 373(23):2203-2214 Link
Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs. a 1:1:2 ratio and mortality in patients with severe trauma: The PROPPR Randomized Clinical Trial. Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O’Keeffe T, Rizoli S, Robinson BRH, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet J-F, Hoyt DB, Pearson GD, Leroux B, van Belle G for the PROPPR Study Group. JAMA 2015; 313(5):471-482. PMCID: PMC4374744 Link
The impact of peri-shock pause of survival from out-of-hospital shockable cardiac arrest during the Resuscitation Outcomes Consortium PRIMED trial. Cheskes S, Schmicker RG, Verbeek PR, Salvido DD, Brown SP, Brooks S, Menegazzi JJ, Vaillancourt C, Powell J, May S, Berg RA, Sell R, Idris A, Kampp M, Schmidt T, Christenson J, and the ROC investigators. Resuscitation 2014; 85:336-342. PMCID: PMC3944081 Link
Early versus later rhythm analysis in patients with out-of-hospital cardiac arrest. Stiell IG, Nichol G, Leroux BG, Rea TD, Ornato JP, Powell J, Christenson J, Callaway CW, Kudenchuk PJ, Aufderheide TP, Idris AH, Daya M, Wang HE, Morrison L, Davis D, Andrusiek D, Stephens S, Cheskes S, Schmicker RH, Fowler R, Vaillancourt C, Hostler D, Zive D, Pirrallo RG, Vilke GM, Sopko G, Weisfeldt M, and the ROC Investigators. New England Journal of Medicine 2011; 365(9):787-797. PMCID: PMC3181067 Link
A trial of an impedance threshold device in out-of-hospital cardiac arrest. Aufderheide TP, Nichol G, Rea TD, Brown SP, Leroux BG, Pepe PE, Kudenchuk PJ, Christenson J, Daya MR, Dorian P, Callaway CW, Idris AH, Andrusiek D, Stephens SW, Hostler D, Davis DP, Dunford JV, Pirrallo RG, Stiell IG, Clement CM, Craig A, Van Ottingham L, Schmidt TA, Wang HE, Weisfeldt ML, Ornato JP, Sopko G, ROC Investigators. New England Journal of Medicine 2011; 365:798-806. PMCID: PMC3204381 Link
Perishock Pause: an independent predictor of survival from out-of-hospital shockable cardiac arrest. Cheskes S, Schmicker RH, Christenson J, Salcido DD, Rea T, Powell J, Edelson DP, Sell R, May S, Menegazzi JJ, Van Ottingham L, Olsufka M, Pennington S, Simonini J, Berg RA, Stiell I, Idris A, Bigham B, Morrison L, on behalf of the Resuscitation Outcomes Consortium (ROC) Investigators. Circulation 2011; 124:158-166. PMCID: PMC3138806 Link
Out-of-hospital hypertonic resuscitation following traumatic hypovolemic shock: a randomized, placebo controlled trial. Bulger EM, May S, Kerby JD, Emerson S, Stiell IG, Schreiber MA, Brasel KJ, Tisherman SA, Coimbra R, Rizoli S, Minei JP, Hata JS, Sopko G, Evans DC, Hoyt DB, ROC Investigators. Annals of Surgery 2011; 253(3):431-441. PMCID: PMC3015143 Link
The relationship between out-of-hospital airway management and outcome among trauma patients with Glasgow Coma Scale scores of 8 or less.Davis DP, Koprowicz KM, Newgard CD, Daya M, Bulger EM, Stiell I, Nichol G, Stephens S, Dreyer J, Minei J, Kerby JD. Prehospital Emergency Care 2011; 15(2):184-92. PMCID: PMC4091894 Link
Ventricular tachyarrythmias following cardiac arrest in public versus home. Weisfeldt ML, Everson-Stewart S, Sitlani C, Rea T, Aufderheide TP, Atkins DL, Bigham B, Brooks SC, Foerster C, Gray R, Ornato JP, Powell J, Kudenchuk PJ, Morrison LJ, ROC Investigators. New England Journal of Medicine 2011; 364:313-21. PMCID: PMC3062845 Link
Out-of-hospital hypertonic resuscitation following severe traumatic brain injury: a randomized controlled trial. Bulger EM, May S, Brasel KJ, Schreiber M, Kerby JD, Tisherman SA, Newgard C, Slutsky A, Coimbra R, Emerson S, Minei JP, Bardarson B, Kudenchuk P, Baker A, Christenson J, Idris A, Davis D, Fabian TC, Aufderheide TP, Callaway C, Williams C, Banek J, Vaillancourt C, van Heest R, Sopko G, Hata JS, Hoyt DB, ROC Investigators. Journal of the American Medical Association 2010; 304(13):1455-1464. PMCID: 3015143 Link
Receiving hospital characteristics associated with survival after out-of-hospital cardiac arrest. Callaway C, Schmicker R, Kampmeyer M, Powell J., Rea T, Daya M, Aufderheide T, Davis D, Rittenberger J, Idris A, Nichol G, ROC Investigators. Resuscitation 2010; 81(6) 524-529. PMCID: PMC2856722 Link
Epidemiology and outcomes from out-of-hospital cardiac arrest in children: The ROC epistry-cardiac arrest. Atkins D, Everson-Stewart S, Sears G, Daya M, Osmond M, Warden C, Berg R. Circulation 2009; 119(11):1484-1491. PMCID: PMC2679169 Link
Regional variation in out-of-hospital cardiac arrest incidence and outcome. Nichol G, Thomas E, Callaway CW, Hedges J, Powell JL, Aufderheide TP, Rea T, Lowe R, Brown T, Dreyer J, Davis D, Idris A, Stiell IG. Journal of the American Medical Association 2008; 300:1423-1431. PMCID: PMC3187919 Link
Rationale, development and implementation of the Resuscitation Outcomes Consortium epistry-cardiac arrest. Morrison LJ, Nichol G, Rea TD, Christenson J, Callaway CW, Stephens S, Pirrallo RG, Atkins DL, Davis DP, Idris AH, Newgard CD. Resuscitation 2008; 78:161-169. PMCID: PMC4159466 Link
Hypertonic resuscitation: Design and implementation of a prehospital intervention trial. Brasel K, Bulger E, Cook A, Morrison, L, Newgard C, Tisherman, S, Kerby J, Coimbra R, Hata S, Hoyt D, ROC Investigators. Journal of the American College of Surgeons 2008; 206(2): 220-232. Link
Phone: (206) 685-1302
Email: uwctc@uw.edu
The UW Clinical Trials Center is an established team of biostatisticians, programmers, and project management staff that have extensive experience designing, planning, implementing, conducting, and monitoring large-scale clinical trials. They bring to the table a broad set of skills, and have an established foundation built on open communication and active collaborative problem solving that has ensured the success of many complex clinical trials.
The center is a critical resource for investigators at the UW and nation-wide who are striving to improve clinical approaches in emergency medicine, cardiovascular disease, and other areas.
For the past 10 years the UW CTC has been the home for the NHLBI sponsored Resuscitation Outcomes Consortium (ROC) a network that consists of 10 Regional Clinical Centers (RCCs), and a Data and Coordinating Center (DCC). ROC provides infrastructure to advance rapid translation of promising scientific and clinical interventions to improve patient outcomes.
We welcome new opportunities for collaboration; please reach out to us at: uwctc@uw.edu
Leadership
Susanne May, Principal Investigator for Resuscitation Outcomes Consortium (ROC)
Gerald van Belle, Principal Investigator (multiple PI with Susanne May) for PROPPR and PROHS Studies
Eileen Bulger, Co-Principal Investigator, Trauma
Scott Emerson, Principal Investigator A-TREAT
Graham Nichol, Co-Principal Investigator and ROC Medical Director
Brian Leroux, Faculty Statistician
Barbara McKnight, Faculty Statistician
Michelle Doyle, Project Director
Jonas Carson, Manager of Data Operations
Members
Ben Bergsten-Buret, Web Application Engineer
Siobhan Brown, Research Scientist
Heather Herren, Project Manager, Cardiac
Delores Kannas, Project Manager, Trauma
Noah Kime, Research Assistant
Winnie Kirdpoo, Web Application Engineer
Umberto Lenzi, Computer and Network Technician
Eric Meier, Research Scientist
Rob Schmicker, Research Scientist
Daniel Shea, Student Assistant
Meghann Seiler, Project Manager
Eshy Shahrazad, Research Coordinator
Ellen Terry, Publications Coordinator
Current UW CTC studies include:
A-TREAT – This study compares the incidences of bleeding and thrombosis and the transfusion requirements in patients randomized to receive TXA or a placebo for hypo-proliferative thrombocytopenia secondary to primary marrow disorders, chemotherapy, immunotherapy, radiation, and/or hematopoietic stem cell transplant.
ALPS – The primary aim of this study was to determine if survival to hospital discharge is improved with early therapeutic administration of a new formulation of IV amiodarone compared to placebo and lidocaine.
PART – This pragmatic trial compares the effectiveness of primary endotracheal intubation versus primary laryngeal tube airway management strategies upon 72-hour survival after out-of-hospital cardiac arrest.
TXA - This multi-center, Phase II trial is designed to determine if tranexamic acid initiated in the prehospital setting improves long-term neurologic outcome compared to placebo in patients with moderate to severe traumatic brain injury who are not in shock.
PROHS – This pragmatic, multicenter, prospective observational study compares the effectiveness of two different existing prehospital resuscitation approaches in severely injured trauma patients transported by air ambulance.
PCAAM – This prospective multicenter observational study seeks to improve understanding of current out-of-hospital pediatric airway management. Patients will be enrolled from participating EMS agencies when there is a treated out-of-hospital cardiac arrest in a patient less than 18 years old.
Epistry – The primary goal of this trial was to develop the rationale and methods for a standard, reliable, and valid epidemiologic databank of out-of-hospital cardiac arrest and life-threatening trauma cases with in-hospital outcomes after five years.
Highlighted Publications
Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest. Kudenchuk PJ, Brown SP, Daya M, Rea T, Nichol G, Morrison LJ, Leroux B, Vaillancourt C, Wittwer L, Callaway CW, Christenson J, Egan D, Ornato JP, Weisfeldt ML, Stiell IG, Idris AH, Aufderheide TP, Dunford JV, Colella MR, Vilke GM, Brienza AM, Desvigne-Nickens P, Gray PC, Gray R, Seals N, Straight R, Dorian P, and the ROC Investigators. New England Journal of Medicine 2016; 374:1711-1722 Link
Trial of continuous or interrupted chest compressions during CPR. Nichol G, Leroux B, Wang H, Callaway CW, Sopko G, Weisfeldt M, Stiell I, Morrison LJ, Aufderheide TP, Cheskes S, Christenson J, Kudenchuk P, Vaillancourt C, Rea TD, Idris AH, Colella R, Isaacs M, Straight R, Stephens S, Richardson J, Condle J, Schmicker RH, Egan D, May S, Ornato JP, and the ROC Investigators. New England Journal of Medicine 2015; 373(23):2203-2214 Link
Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs. a 1:1:2 ratio and mortality in patients with severe trauma: The PROPPR Randomized Clinical Trial. Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O’Keeffe T, Rizoli S, Robinson BRH, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet J-F, Hoyt DB, Pearson GD, Leroux B, van Belle G for the PROPPR Study Group. JAMA 2015; 313(5):471-482. PMCID: PMC4374744 Link
The impact of peri-shock pause of survival from out-of-hospital shockable cardiac arrest during the Resuscitation Outcomes Consortium PRIMED trial. Cheskes S, Schmicker RG, Verbeek PR, Salvido DD, Brown SP, Brooks S, Menegazzi JJ, Vaillancourt C, Powell J, May S, Berg RA, Sell R, Idris A, Kampp M, Schmidt T, Christenson J, and the ROC investigators. Resuscitation 2014; 85:336-342. PMCID: PMC3944081 Link
Early versus later rhythm analysis in patients with out-of-hospital cardiac arrest. Stiell IG, Nichol G, Leroux BG, Rea TD, Ornato JP, Powell J, Christenson J, Callaway CW, Kudenchuk PJ, Aufderheide TP, Idris AH, Daya M, Wang HE, Morrison L, Davis D, Andrusiek D, Stephens S, Cheskes S, Schmicker RH, Fowler R, Vaillancourt C, Hostler D, Zive D, Pirrallo RG, Vilke GM, Sopko G, Weisfeldt M, and the ROC Investigators. New England Journal of Medicine 2011; 365(9):787-797. PMCID: PMC3181067 Link
A trial of an impedance threshold device in out-of-hospital cardiac arrest. Aufderheide TP, Nichol G, Rea TD, Brown SP, Leroux BG, Pepe PE, Kudenchuk PJ, Christenson J, Daya MR, Dorian P, Callaway CW, Idris AH, Andrusiek D, Stephens SW, Hostler D, Davis DP, Dunford JV, Pirrallo RG, Stiell IG, Clement CM, Craig A, Van Ottingham L, Schmidt TA, Wang HE, Weisfeldt ML, Ornato JP, Sopko G, ROC Investigators. New England Journal of Medicine 2011; 365:798-806. PMCID: PMC3204381 Link
Perishock Pause: an independent predictor of survival from out-of-hospital shockable cardiac arrest. Cheskes S, Schmicker RH, Christenson J, Salcido DD, Rea T, Powell J, Edelson DP, Sell R, May S, Menegazzi JJ, Van Ottingham L, Olsufka M, Pennington S, Simonini J, Berg RA, Stiell I, Idris A, Bigham B, Morrison L, on behalf of the Resuscitation Outcomes Consortium (ROC) Investigators. Circulation 2011; 124:158-166. PMCID: PMC3138806 Link
Out-of-hospital hypertonic resuscitation following traumatic hypovolemic shock: a randomized, placebo controlled trial. Bulger EM, May S, Kerby JD, Emerson S, Stiell IG, Schreiber MA, Brasel KJ, Tisherman SA, Coimbra R, Rizoli S, Minei JP, Hata JS, Sopko G, Evans DC, Hoyt DB, ROC Investigators. Annals of Surgery 2011; 253(3):431-441. PMCID: PMC3015143 Link
The relationship between out-of-hospital airway management and outcome among trauma patients with Glasgow Coma Scale scores of 8 or less.Davis DP, Koprowicz KM, Newgard CD, Daya M, Bulger EM, Stiell I, Nichol G, Stephens S, Dreyer J, Minei J, Kerby JD. Prehospital Emergency Care 2011; 15(2):184-92. PMCID: PMC4091894 Link
Ventricular tachyarrythmias following cardiac arrest in public versus home. Weisfeldt ML, Everson-Stewart S, Sitlani C, Rea T, Aufderheide TP, Atkins DL, Bigham B, Brooks SC, Foerster C, Gray R, Ornato JP, Powell J, Kudenchuk PJ, Morrison LJ, ROC Investigators. New England Journal of Medicine 2011; 364:313-21. PMCID: PMC3062845 Link
Out-of-hospital hypertonic resuscitation following severe traumatic brain injury: a randomized controlled trial. Bulger EM, May S, Brasel KJ, Schreiber M, Kerby JD, Tisherman SA, Newgard C, Slutsky A, Coimbra R, Emerson S, Minei JP, Bardarson B, Kudenchuk P, Baker A, Christenson J, Idris A, Davis D, Fabian TC, Aufderheide TP, Callaway C, Williams C, Banek J, Vaillancourt C, van Heest R, Sopko G, Hata JS, Hoyt DB, ROC Investigators. Journal of the American Medical Association 2010; 304(13):1455-1464. PMCID: 3015143 Link
Receiving hospital characteristics associated with survival after out-of-hospital cardiac arrest. Callaway C, Schmicker R, Kampmeyer M, Powell J., Rea T, Daya M, Aufderheide T, Davis D, Rittenberger J, Idris A, Nichol G, ROC Investigators. Resuscitation 2010; 81(6) 524-529. PMCID: PMC2856722 Link
Epidemiology and outcomes from out-of-hospital cardiac arrest in children: The ROC epistry-cardiac arrest. Atkins D, Everson-Stewart S, Sears G, Daya M, Osmond M, Warden C, Berg R. Circulation 2009; 119(11):1484-1491. PMCID: PMC2679169 Link
Regional variation in out-of-hospital cardiac arrest incidence and outcome. Nichol G, Thomas E, Callaway CW, Hedges J, Powell JL, Aufderheide TP, Rea T, Lowe R, Brown T, Dreyer J, Davis D, Idris A, Stiell IG. Journal of the American Medical Association 2008; 300:1423-1431. PMCID: PMC3187919 Link
Rationale, development and implementation of the Resuscitation Outcomes Consortium epistry-cardiac arrest. Morrison LJ, Nichol G, Rea TD, Christenson J, Callaway CW, Stephens S, Pirrallo RG, Atkins DL, Davis DP, Idris AH, Newgard CD. Resuscitation 2008; 78:161-169. PMCID: PMC4159466 Link
Hypertonic resuscitation: Design and implementation of a prehospital intervention trial. Brasel K, Bulger E, Cook A, Morrison, L, Newgard C, Tisherman, S, Kerby J, Coimbra R, Hata S, Hoyt D, ROC Investigators. Journal of the American College of Surgeons 2008; 206(2): 220-232. Link
Phone: (206) 685-1302
Email: uwctc@uw.edu