CITR Annual Report Report Exhibits CITR Annual Exhibits Prepared by: CITR Coordinating Center The EMMES Corporation Rockville, MD Sponsored by: National Institute of Diabetes & Digestive & Kidney Diseases National Institutes of Health Bethesda, MD Datafile Closure: April 3, 2006 Table of Contents Section 1: Registry Summary Section 2: Islet Transplant Alone Information Chapter 1: Participant and Donor Characteristics Chapter 2: Pancreas Procurement and Islet Processing Chapter 3: Immunosuppressive and Other Medications Chapter 4: Graft Function Chapter 5: Recipient’s Laboratory Data Chapter 6: Adverse Events Section 3: Islet After Kidney Transplant Information Section 4: Registry Data Quality Review CITR Coordinating Center CITR Committees Section 1: Registry Summary Contributing Islet Transplant Centers (N=23) Number of Islet Transplant Programs Transplanting and Number Reporting Information to CITR by Year Total Number of Recipients Receiving Their First Islet Allograft Infusion in North America as Reported to the Registry and Number Contained in the Annual Report The Islet Transplant Summary (ITS) questionnaire is completed by all North American Islet Transplant Programs regardless of their participation in the Registry. Of 42 North American islet transplant programs polled, all have provided this information through 2005. Total Number of Islet Allograft Infusion Procedures Performed in North America as Reported to the Registry and Number Contained in the Annual Report The Islet Transplant Summary (ITS) questionnaire is completed by all North American islet transplant programs regardless of their participation in the Registry. Of 42 North American islet transplant programs polled, all have provided this information through 2005. Total Number of Islet Allograft Infusion Procedures Conducted and Entered in CITR Database by Year and by Infusion Procedure Number (All Participants, N=225) Total Number of Islet Allograft Infusion Procedures Received Per Participant (All Participants, N=225) Summary of Transplant Types (All Participants, N=227) Section 2: Islet Transplant Alone Information Chapter 1: Participant and Donor Characteristics Participant Demographics Participant Summary Measures at First Infusion Participant Characteristics Participant’s Primary Payer and Employment Status at Time of First Infusion Participant Status at First Infusion Participant Status at First Infusion (continued) Participant Serology at Screening Participant Baseline Demographics Prior to First Infusion by Total Number of Infusions Received Participant Demographics Prior to First Infusion by Total Number of Infusions Received Infusion Summary by Infusion Sequence Infusion Summary by Infusion Sequence (continued) Pre Infusion Portal Pressure (mmHg) by Infusion Sequence Peak Portal Pressure (mmHg) by Infusion Sequence Closure Portal Pressure (mmHg) by Infusion Sequence Change from Pre Infusion to Closure Portal Pressure (mmHg) by Infusion Sequence Change from Pre Infusion to Peak Portal Pressure (mmHg) by Infusion Sequence Packed Cell Volume (mL) Used During Infusion by Infusion Year Donor Characteristics Donor Characteristics and Hospitalization Summary Information Donor Characteristics and Hospitalization Summary Information (continued) Donor Characteristics and Hospitalization Summary Information (continued) Donor Characteristics and Hospitalization Summary Information (continued) Donor Age (yrs) Donor Weight (kg) Donor Body Mass Index (kg/m2) Time from Cross Clamp to Pancreas Recovery (mins) Donor Characteristics: Use of Vasopressors Donor Serology Donor Laboratory Data Donor Serum Creatinine (mg/dL) Donor BUN (mg/dL) Donor Total Bilirubin (mg/dL) Donor AST (IU/L) Donor ALT (IU/L) Donor Serum Lipase (IU/L) Donor Serum Amylase (IU/L) Donor Pre-Insulin Blood Glucose (mg/dL) Donor Maximum Blood Glucose (mg/dL) Chapter 2: Pancreas Procurement and Islet Processing Islet Processing Summary Islet Processing Summary (continued) Cold Ischemia Information Summary of Islet Equivalents and Timing of Count Islet Product Characterization Total Islet Equivalents by Cold Ischemic Time (hrs) All Pancreas Preservation Methods Total Islet Equivalents by Cold Ischemic Time (hrs) Pancreata Preserved with UW Only Total Islet Equivalents by Cold Ischemic Time (hrs) Pancreata Preserved with Two Layer Only Total Islet Equivalents by Donor Body Mass Index (kg/m2) Total Islet Equivalents by Donor Age (yrs) Islet Characteristics by Time from Cross Clamp to Pancreas Recovery Islet Characteristics by Pancreas Preservation Method Islet Characteristics by Cold Ischemic Time (hrs) Islet Characteristics by Islet Pretreatment Method Islet Characteristics by Donor Age (hrs) Islet Characteristics by Donor Body Mass Index (kg/m2) Mean Number of Islet Equivalents/kg Participant ( SD) by Total Number of Infusions Received (Recipients with a Total of 1 Infusion, 2 Infusions, and 3 Infusions) Chapter 3: Immunosuppressive and Other Medications Immunosuppression Regimen at Time of First Infusion Summary of T Cell Antibodies Used During First Infusion for Induction Therapy Immunosuppression Dosing (mg/day) at Time of Infusion by Infusion Sequence Induction Therapy at Time of Infusion by Infusion Sequence Immunosuppression Therapy Use Post Last Infusion Immunosuppression Dosing Post Last Infusion Sirolimus Trough Level (ng/mL) Post Last Infusion Tacrolimus Trough (ng/mL) Level Post Last Infusion Use of Anti-Hypertensive Medications at Pre Infusion and Post Last Infusion Percent of Participants Using Anti-Hypertensive Medications at Pre Infusion and Post Last Infusion Use of Lipid Lowering Medications Pre Infusion and Post Last Infusion Percent of Participants Using Lipid Lowering Medications at Pre Infusion and Post Last Infusion Adjunctive Therapy Used at Time of First Infusion Adjunctive Therapy Used During Follow-Up Post Last Infusion Adjunctive Therapy Used During Follow-Up Post Last Infusion (continued) Chapter 4: Graft Function Participant’s Insulin Status at Follow-up Post First and Last Infusion Participant’s Insulin Status at Follow-Up Post Last Infusion by Total Number of Infusions Received Percent of Participants Ever Achieving Insulin Independence Percent of Participants Ever Achieving Insulin Independence by the Infusion Received When Insulin Independence was Achieved Time to Return to Insulin Dependence ( 14 Days of Insulin Use) Among Insulin Independent Participants Time to Return to Insulin Dependence ( 14 Days of Insulin Use) Stratified by Total Number of Infusions Needed to First Achieve Insulin Independence Among Insulin Independent Participants Percent of Participants by Outcome Level at Follow-Up Post Last Infusion Insulin Status (%) by Follow-Up Visit Post Last Infusion Percent of Insulin Independent Participants Post Last Infusion Percent of Insulin Independent Participants Post Last Infusion by Total Number of Infusions Received Reduction of Insulin (%) From Baseline to Follow-Up Post Last Infusion Participants on Insulin Average Daily Insulin Use (Units) at Follow-Up Post Last Infusion Participants on Insulin Percentage of Baseline Insulin Use at Follow-Up Post Last Infusion Recipients Ever Achieving Insulin Independence Percentage of Baseline Insulin Use at Follow-Up Post Last Infusion Recipients Never Achieving Insulin Independence Average Daily Insulin Use (Units/kg) at Baseline and Post Last Infusion Participants on Insulin Insulin Independence (%) Year 1 Post First Infusion by Participant’s Weight (kg) at Baseline Insulin Independence (%) Year 1 Post First Infusion by Participant’s Average Daily Insulin Use (Units/Day) at Baseline Insulin Independence at Month 6 and Year 1 Post Last Infusion by Donor and Participant Characteristics Insulin Independence at Month 6 and Year 1 Post Last Infusion by Donor and Participant Characteristics (continued) Basal C-Peptide 0.5 ng/mL at Month 6 and Year 1 Post Last Infusion by Donor and Participant Characteristics Basal C-Peptide 0.5 ng/mL at Month 6 and Year 1 Post Last Infusion by Donor and Participant Characteristics (continued) HbA1C 6.5% at Month 6 and Year 1 Post Last Infusion by Donor and Participant Characteristics HbA1C 6.5% at Month 6 and Year 1 Post Last Infusion by Donor and Participant Characteristics (continued) Outcome Levels at Month 6 Post Last Infusion by Donor and Participant Characteristics Outcome Levels at Month 6 Post Last Infusion by Donor and Participant Characteristics (continued) Outcome Levels at Year 1 Post Last Infusion by Donor and Participant Characteristics Outcome Levels at Year 1 Post Last Infusion by Donor and Participant Characteristics (continued) Participant Outcome at Month 6 Post Last Infusion by Mean Donor Age Over All Infusions (yrs) Participant Outcome at Year 1 Post Last Infusion by Mean Donor Age Over All Infusions (yrs) Participant Outcome at Month 6 Post Last Infusion by Participant Age at Baseline (yrs) Participant Outcome at Year 1 Post Last Infusion by Participant Age at Baseline (yrs) Participant Outcome at Month 6 Post Last Infusion by Duration of Diabetes at Baseline (yrs) Participant Outcome at Year 1 Post Last Infusion by Duration of Diabetes at Baseline (yrs) Participant Outcome at Month 6 Post Last Infusion by Participant Body Mass Index (kg/m2) Participant Outcome at Year 1 Post Last Infusion by Participant Body Mass Index (kg/m2) Participant Outcome at Month 6 Post Last Infusion by Insulin Use (Units/kg Participant Weight at Baseline) Participant Outcome at Year 1 Post Last Infusion by Insulin Use (Units/kg Participant Weight at Baseline) Participant Outcome at Month 6 Post Last Infusion by Participant Gender Participant Outcome at Year 1 Post Last Infusion by Participant Gender Participant Outcome at Month 6 Post Last Infusion by Any Elevated Liver Function Tests Prior to Assessment Participant Outcome at Year 1 Post Last Infusion by Any Elevated Liver Function Tests Prior to Assessment Participant Outcome at Month 6 Post Last Infusion by Any Adverse Event Related to Infusion Prior to Assessment Participant Outcome at Year 1 Post Last Infusion by Any Adverse Event Related to Infusion Prior to Assessment Participant Outcome at Month 6 Post Last Infusion by Mean Donor Body Mass Index (kg/m2) Participant Outcome at Year 1 Post Last Infusion by Mean Donor Body Mass Index (kg/m2) Participant Outcome at Month 6 Post Last Infusion by Islet Equivalents/kg Participant Weight Participant Outcome at Year 1 Post Last Infusion by Islet Equivalents/kg Participant Weight Summary of Severe Hypoglycemic Events Pre First Infusion and Follow-Up Post Last Infusion Percent of Participants with One or More Occurrences of Severe Hypoglycemic Episodes Pre First Infusion and Follow-Up Post Last Infusion Insulin Independence by Immunosuppression Regimen Insulin Independence at Month 6 by Immunosuppression Regimen All Participants on Sirolimus, Tacrolimus, and Daclizumab at Baseline Insulin Independence at Year 1 by Immunosuppression Regimen All Participants on Sirolimus, Tacrolimus, and Daclizumab at Baseline Insulin Status at Post Last Infusion Follow-Up and Sirolimus Trough Level (ng/mL) Insulin Status at Post Last Infusion Follow-Up and Tacrolimus Trough Level (ng/mL) Fasting Plasma Glucose (mg/dL) Pre Infusion and Post Last Infusion HbA1C (%) Pre Infusion and Post Last Infusion Basal Plasma C-Peptide (ng/mL) Pre Infusion and Post Last Infusion Fasting Plasma Glucose (mg/dL) Pre Infusion and Post Last Infusion Participants with One Infusion HbA1C (%) Pre Infusion and Post Last Infusion Participants with One Infusion Basal Plasma C-peptide (ng/mL) Pre Infusion and Post Last Infusion Participants with One Infusion Fasting Plasma Glucose (mg/dL) Pre Infusion and Post Last Infusion Participants with Two Infusions HbA1C (%) Pre Infusion and Post Last Infusion Participants with Two Infusions Basal Plasma C-peptide (ng/mL) Pre Infusion and Post Last Infusion Participants with Two Infusions Fasting Plasma Glucose (mg/dL) Pre Infusion and Post Last Infusion Participants with Three Infusions HbA1C (%) Pre Infusion and Post Last Infusion Participants with Three Infusions Basal Plasma C-peptide (ng/mL) Pre Infusion and Post Last Infusion Participants with Three Infusions Fasting Plasma Glucose (mg/dL) Post Last Infusion Participants Who Ever Achieved Insulin Independence Fasting Plasma Glucose (mg/dL) Post Last Infusion Participants Who Never Achieved Insulin Independence HbA1C (%) Post Last Infusion Participants Who Ever Achieved Insulin Independence HbA1C (%) Post Last Infusion Participants Who Never Achieved Insulin Independence Basal Plasma C-Peptide (ng/mL) Post Last Infusion Participants Who Ever Achieved Insulin Independence Basal Plasma C-Peptide (ng/mL) Post Last Infusion Participants Who Never Achieved Insulin Independence Fasting Plasma Glucose (mg/dL) Pre and Post First Infusion Insulin Independent Participants Fasting Plasma Glucose (mg/dL) Pre and Post First Infusion Insulin Dependent Participants HbA1C (%) Pre and Post First Infusion Insulin Independent Participants HbA1C (%) Pre and Post First Infusion Insulin Dependent Participants Basal Plasma C-peptide (ng/mL) Pre and Post First Infusion Insulin Independent Participants Basal Plasma C-peptide (ng/mL) Pre and Post First Infusion Insulin Dependent Participants Participants with Fasting Blood Glucose < 126 mg/dL Post Last Infusion All Participants Participants with Basal C-Peptide 0.5 ng/mL Post Last Infusion All Participants Participants with HbA1C 6.5 % Post Last Infusion All Participants Pre Infusion Recipient Lab Summary by Infusion Sequence Metabolic Summary by Follow-Up Post Last Infusion Metabolic Summary Month 6 Post Last Infusion by Insulin Status Metabolic Summary Year 1 Post Last Infusion by Insulin Status Change in Islet Graft Function and Recipient Survival Summary Post Last Infusion *One recipient died 70 days following their third islet cell infusion. The cause of death for this recipient was reported as acute methadone and diphenhydramine toxicity unrelated to both the infusion procedure and immunosuppression therapy. An additional recipient death has been reported which occurred after Year 3 post last infusion. The cause of death for this recipient was reported as viral meningitis possibly related to the immunosuppression therapy. Finally, a third death was reported which occurred after Year 4 post last infusion. The death was discovered in the obituaries and the cause of death is unknown. Change in Islet Graft Function Summary Change in Islet Graft Function Summary (continued) Change in Islet Graft Function Summary (continued) Time to Complete Islet Graft Failure All Participants from Centers Reporting Islet Graft Failures Summary of Secondary Complications Pre First Infusion and Post Last Infusion Summary of Secondary Complications Pre First Infusion and Post Last Infusion (continued) Summary of Secondary Complications Pre First Infusion and Post Last Infusion (continued) Summary of Ocular Complications Post Last Infusion Chapter 5: Recipient’s Laboratory Data Participants with Abnormal Liver Function Tests Post Infusion Participants with Abnormal Liver Function Tests Post Infusion (continued) ALT (IU/L) Pre Infusion and Post Last Infusion AST (IU/L) Pre Infusion and Post Last Infusion Alkaline Phosphatase (IU/L) Pre Infusion and Post Last Infusion Total Bilirubin (mg/dL) Pre Infusion and Post Last Infusion Participants with Abnormal Lipid Tests Post First Infusion Participants with Abnormal Lipid Tests Post First Infusion (continued) Total Cholesterol (mg/dL) Pre Infusion and Post Last Infusion HDL (mg/dL) Pre Infusion and Post Last Infusion LDL (mg/dL) Pre Infusion and Post Last Infusion Triglycerides (mg/dL) Pre Infusion and Post Last Infusion Percent of Participants with an Increase in Serum Creatinine (mg/dL) Greater than 0.5 from Baseline Serum Creatinine (mg/dL) Pre Infusion and Post Last Infusion Calculated Creatinine Clearance (mL/min/1.73m2) Pre Infusion and Post Last Infusion Chapter 6: Adverse Events Summary of Adverse Events and Serious Adverse Events (SAEs) in Year 1 Post First Infusion (Participants, N=203) Percent of Participants with a Serious Adverse Event in Year 1 Post First Infusion by Year of Infusion Summary of All Serious Adverse Events (SAEs) Reported by Type of SAE Summary of All Serious Adverse Events (SAEs) Reported and their Outcome Summary of All Serious Adverse Events (SAEs) Reported by System Organ Class Summary of All Serious Adverse Events (SAEs) Reported by System Organ Class (continued) Most Common Serious Adverse Events (SAEs), Reported for All Participants (Total SAEs, N=236) All Serious Adverse Events (SAEs) Reported in Alphabetical Order All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) Summary of Reported Neoplasms (benign, malignant, unspecified) All Participants Number of Days Hospitalized at Infusion (Admission to Discharge) by Infusion Sequence Hospitalizations Experienced Post Last Infusion by Total Number of Infusions Received Section 3: Islet After Kidney Transplant Information Participant Demographics Participant Characteristics Participant’s Primary Payer and Employment Status at Time of First Infusion Participant Status at First Infusion Participant Status at First Infusion (continued) Participant Summary Measures at First Infusion Participant Serology at Screening Infusion Summary by Infusion Sequence Donor Characteristics Donor Characteristics and Hospitalization Summary Information Donor Characteristics and Hospitalization Summary Information (continued) Donor Characteristics and Hospitalization Summary Information (continued) Donor Characteristics and Hospitalization Summary Information (continued) Donor Characteristics: Use of Vassopressors Donor Serology Donor Laboratory Data Islet Processing Summary Islet Processing Summary (continued) Cold Ischemia Information Summary of Islet Equivalents and Timing of Count Islet Product Characterization Mean Number of Islet Equivalents/kg (SD) by Total Number of Infusions Received Immunosuppression Regimen at Time of First Infusion Immunosuppression Dosing (mg/day) at Time of Infusion by Infusion Sequence Induction Therapy (mg) at Time of Infusion by Infusion Sequence Immunosuppression Therapy Use Post Last Infusion Immunosuppressive Dosing Post Last Infusion Sirolimus Trough Level (ng/mL) Post Last Infusion Tacrolimus Trough Level (ng/mL) Post Last Infusion Participant’s Insulin Status at Follow-Up Post First and Last Infusion Reduction in Insulin (%) from Pre Infusion to Follow-Up Post Last Infusion Participants on Insulin Summary of Severe Hypoglycemic Events by Pre First Infusion and Follow-Up Post Last Infusion Fasting Plasma Glucose (mg/dL) Pre Infusion and Post Last Infusion HbA1C (%) Pre Infusion and Post Last Infusion Basal Plasma C-peptide (ng/mL) Pre Infusion and Post Last Infusion Pre Infusion Recipient Lab Summary by Infusion Sequence Participants with Abnormal Liver Function Tests Post Infusion Participants with Abnormal Liver Function Tests Post Infusion (continued) ALT (IU/L) Pre Infusion and Post Last Infusion AST (IU/L) Pre Infusion and Post Last Infusion Alkaline Phosphatase (IU/L) Pre Infusion and Post Last Infusion Total Bilirubin (mg/dL) Pre Infusion and Post Last Infusion Participants with Abnormal Lipid Tests Post Infusion Participants with Abnormal Lipid Tests Post Infusion (continued) Total Cholesterol (mg/dL) Pre Infusion and Post Last Infusion HDL (mg/dL) Pre Infusion and Post Last Infusion LDL (mg/dL) Pre Infusion and Post Last Infusion Triglycerides (mg/dL) Pre Infusion and Post Last Infusion Percent of Participants with an Increase in Serum Creatinine (mg/dL) Greater than 0.5 from Baseline Serum Creatinine (mg/dL) Pre Infusion and Post Last Infusion Calculated Creatinine Clearance (mL/min/1.73m2) Pre Infusion and Post Last Infusion Summary of Adverse Events and Serious Adverse Events in Year 1 Post First Infusion (Participants, N=22) Summary of All Serious Adverse Events (SAEs) by Type of SAE Summary of All Serious Adverse Events (SAEs) Reported and their Outcome Summary of All Serious Adverse Events (SAEs) by System Organ Class Summary of All Serious Adverse Events (SAEs) by System Organ Class (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued) Number of Days Hospitalized at Infusion (Admission to Discharge) by Infusion Sequence Hospitalizations Experienced Post Last Infusion by Total Number of Infusions Received Changes in Portal Pressure (mmHg) and Infusion Summary by Infusion Sequence Changes in Portal Pressure (mmHg) and Infusion Summary by Infusion Sequence (continued) Section 4: Registry Data Quality Review Expected and Submitted Forms by Infusion Sequence (All Participants, N=227) Expected and Submitted Follow-Up Forms Post Last Infusion Extent of Follow-Up Post Last Infusion (All Participants, N=227) Summary of All Participants Reported as Lost to CITR Follow-Up CITR Coordinating Center (July 2005 – July 2006) PI: Nicole Close Co-PI: Donald Stablein Bryan Calaway James Cravens Yong Lin Jessica Long Glenn Tucker Chuck Wagner Steve Wease CITR Committees Scientific Advisory Committee (SAC) Compliance Committee Data Monitoring Committee Publications/Presentations Committee Transplant Coordinators’/Data Managers’ Committee CITR Scientific Advisory Committee (SAC) Chair: Bernhard J. Hering Reinhard G. Bretzel Michael Cecka Mary D. Ellison Olle Korsgren Jerry P. Palmer Camillo Ricordi A.M. James Shapiro CITR Compliance Committee Michael Appel E. Brian Flanagan Fouad Kandeel Eileen M. Markmann David Radosevich Marti Sears Elyse Stuart CITR Data Monitoring Committee Chair: Marc Garfinkel David Baidal Enrico Cagliero Fouad Kandeel Dixon Kaufman Jeff Longmate Melissa Roberts Marti Sears CITR Publications/Presentations Committee Chair: Rodolfo Alejandro Michael Appel Nancy Bridges Elizabeth Holbrook Ali Naji A.M. James Shapiro Craig Smith CITR Transplant Coordinators’/ Data Managers’ Committee Chair: Marti Sears Debra Kemp Grace Sauzier David Baidal Carol Kramer Jill Sheedy Terri Baker Kathleen LaBranche KD Shiang Susan Comninel Linda Langman Paige Schock Barbara Culbreath Arlene LaRose Winsor Simmons Arthur Dea Lorraine Lesiecki Elyse Stuart Parastoo Dinyari Eileen Markmann Pat Swanson Cheryl Durkop Marli McCulloch-Olson Heather Turgeon Debbie Grice Deborah McGhee-Wilson Terri Wakefield Darrell Grimes Lori Otken Kimber Westbrook Jeannette Hacker Maral Palanjian Deana Williams Celia Hartigan Jamen Parkey Piotr Witkowski Elizabeth Holbrook Melissa Roberts Elizabeth Wright Robin Jevne Donna Sarman Tiffany Zgabay