NCT02073435|CompletedResultsDMC
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Sponsor study identifier
Secondary identifiers
NIH
observational
177
1 country
4
Study Start
October 2010
Actual (reported)Primary Completion
May 2015
Actual (reported)Study Completion
April 2018
Actual (reported)Living donor liver transplantation (LDLT), involves complex systems and processes of care that are particularly vulnerable to medical errors and preventable complications. This ancillary study of the Adult-to-Adult Living Liver Transplantation Cohort Study (A2ALL) will focus on conducting a proactive, systematic, and comprehensive assessment of the vulnerabilities in the systems and process of LDLT care to reduce medical errors and preventable complications thereby improving the safety of LDLT care. This project will address an important gap in the knowledge needed to achieve high quality and safe LDLT care of patients by developing a process to: 1) proactively, systematically and comprehensively identify areas of vulnerabilities in LDLT care that can result in medical errors, 2) design and implement solutions to mitigate these weaknesses, and 3) evaluate the effectiveness of these solutions to improve the safety of LDLT care by measuring clinical and process outcomes before and after solution implementation across four A2ALL participating transplant centers
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2010
Actual (reported)June 20, 2013
Actual (reported)February 27, 2014
Actual (reported)May 2015
Actual (reported)April 2018
Actual (reported)December 5, 2018
Actual (reported)Living Donor Pain Management
Comparison of Average Pain Scores on Visual Analogue Pain Scale (0-10) measured before and after implementation of evidence-based donor pain management solution. 0 representing "No Pain", up through 10 representing "Worst possible, unbearable, excruciating pain".
Daily Visual Analogue Pain Scores (0-10) At transplant (post-operative day 0) and throughout hospitalization (post-operative days 1-8)
Complications
Cardiopulmonary complications
Perioperatively
Living Donor Liver Transplant patients with evidence based donor pain management solution.
Living Donor Liver Transplant patients prior to the implementation of the evidence based donor pain management solution.
The evidence-based donor pain management solution entails the following elements: Preoperative Assessment and Management: * Assessment of Patient Risk factors for Respiratory Depression (e.g. OSA Assessment: STOP BANG Questionnaire) * Bowel preparation (e.g. Colace or Golytely) * Patient Postoperative Pain Education - Educational handout on postoperative pain At the end of the case in OR: * Local Anesthetic (TAP block, OnQ device, intrathecal, local infiltration) * I.V. Ketorolac (when adequate hemostasis is determined by surgeon and urine output is \> 500cc) * I.V. Steroids (Dexamethasone or Solumedrol) Postoperative Management: * NSAIDS x 72 hours followed by po cox-inhibitor until discharge (e.g. Celecoxib) * Opioids (Dilaudid PCA followed by oral opioids (e.g., Tylenol #3)) Postoperative Assessment: o CO2 monitoring in PACU/ICU for early monitoring of respiratory depression
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CLINICIANS: All clinicians who are involved in the inpatient care provided to the LDLT A2ALL donors and recipients are eligible for the study. The group of clinicians eligible for the study involve all clinicians participating in the LDLT care between day of surgery through discharge: OR personnel (nurses, technicians, anesthesiologists, surgeons, research staff, cell saver staff, etc.), PACU/Intensive Care Unit personnel (nurses, anesthesiologists, surgeons, pharmacists, etc.) and floor personnel (nursing, coordinators, pharmacists, etc.). PATIENTS: Living Donor Liver Transplant patients (donor and recipients) from 2008-2015.
Northwestern University
Chicago, Illinois, 60611, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Columbia University
New York, New York, 10032, United States
Virginia Commonweath University-Medical College of Virginia
Richmond, Virginia, 23298, United States
This study was originally intended to be a clinical trial, with control and intervention sites, however, per discussions with the NIDDK program officer the study design was changed to a observational study.
Daniela Ladner, MD MPH
Northwestern Univesity
Donna Woods, PhD
Northwestern University
Averell Sherker, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
177 participants (actual enrollment reported by the registry).
First Submitted
June 20, 2013
First Posted
February 27, 2014
Study Start
October 2010
Actual (reported)Hepatocyte Matrix Implant Study
Contact the study team to confirm eligibility.
Primary Completion
May 2015
Actual (reported)Study Completion
April 2018
Actual (reported)Last Updated
December 5, 2018
Results First Posted
December 5, 2018
Record last verified: 2018-11
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Source: ClinicalTrials.gov.
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