Phase I Clinical Trial with the AMC-Bioartificial Liver

2002 ◽  
Vol 25 (10) ◽  
pp. 950-959 ◽  
Author(s):  
M.-P. Van De Kerkhove ◽  
E. Di Florio ◽  
V. Scuderi ◽  
A. Mancini ◽  
A. Belli ◽  
...  

Recently a bio-artificial liver (BAL) system has been developed at the Academic Medical Center (AMC) of Amsterdam to bridge patients with acute liver failure (ALF) to orthotopic liver transplantation (OLT). After successful testing of the AMC-BAL in rodents and pigs with ALF, a phase I study in ALF patients waiting for (OLT) was started in Italy. We present the safety outcome of the first 7 patients aged 21–56 years with coma grade III or IV. The total AMC-BAL treatment time ranged from 8 to 35 hours. Three patients received 2 treatments with two different BAL's within three days. Six of the 7 patients were successfully bridged to OLT. One patient showed improved liver function after two treatments and did not need OLT. No severe adverse events of the BAL treatment were noted. Conclusion Treatment of ALF patients with the AMC-BAL is a safe and feasible technique to bridge the waiting time for an adequate liver-graft.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 136-136
Author(s):  
Chad W. Cummings ◽  
Becky Habecker ◽  
Katherine Tullio ◽  
Andrew Rothacker ◽  
Nathan A. Pennell ◽  
...  

136 Background: Value-Stream Mapping (VSM) was employed to evaluate non-value added activities focused on minimizing time between pathological diagnosis and first treatment (Time-To-Treat or TTT). Objective is to identify unnecessary delays in care for NSLC patients treated at a large academic medical center. Methods: A total of 253 patient records were examined between 1/15/2015 and 7/19/2016 and divided into stages: Stage I (Non-Surgical), Stage I-II (Surgical), Stage III, and Stage IV. Selection criteria required a min. of 50 patients/stage, including internally and externally diagnosed patients. A VSM was developed for each stage. Spreadsheets were used to detail dates and sequences of events, including consults, E&M visits, imaging, procedures, and testing. Results: Overall TTT results by stage (median days) are as follows: Stage I (Non-Surgical) = 46 days (n = 55), Stage I-II (Surgical) = 35 days, n = 50), Stage III = 34 days (n = 71), Stage IV = 19 days (n = 77). Consults were reviewed among 4 specialties (Med/Onc, Rad/Onc, Surgical, Pulmonary), revealing Pulmonary Consults most common regardless of stage, 38%, 40%, 49%, 29%, respectively. It was found consults among specialties were rarely coordinated (stage III: 11/70 patients had consults same day between 2 specialties). Bronchoscopy procedures were most common method of Dx; sampling (n = 60, all stages) revealed MD orders are placed within 1 median day for each stage (15% ≥ 5days), but lead time to procedure ranged 7-12 median days depending on stage. Comorbidities for surgical patients (n = 46) were reviewed and found TTT delays correlates with number of comorbidities and FEV1 test results. Interventions included weekly, multi-disciplinary identification and review of patients across the 4 specialties, development of a TTT visual dashboard, and creation of communication standards across specialties. Conclusions: A VSM will identify areas where excessive delays occur. Opportunities exist to combine activities (same-day appointments/consults), reduce delays between activities, and/or improve communication. Decision-making can be accelerated when time between events (consults, staging, procedures, and tests) is minimized, regardless of diagnosis origin.


2002 ◽  
Vol 2 (3) ◽  
pp. 95-104 ◽  
Author(s):  
JoAnn Manson ◽  
Beverly Rockhill ◽  
Margery Resnick ◽  
Eleanor Shore ◽  
Carol Nadelson ◽  
...  

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