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Titolo:
Safety observations in Phase I clinical evaluation of the Excorp Medical Bioartificial Liver Support System after the first four patients
Autore:
Mazariegos, GV; Kramer, DJ; Lopez, RC; Shakil, AO; Rosenbloom, AJ; DeVera, M; Giraldo, M; Grogan, TA; Zhu, Y; Fulmer, ML; Amiot, BP; Patzer, JF;
Indirizzi:
Univ Pittsburgh, Dept Surg, Pittsburgh, PA 15261 USA Univ Pittsburgh Pittsburgh PA USA 15261 pt Surg, Pittsburgh, PA 15261 USA Univ Pittsburgh, Thomas E Starzl Transplantat Inst, Pittsburgh, PA USA Univ Pittsburgh Pittsburgh PA USA Transplantat Inst, Pittsburgh, PA USA Univ Pittsburgh, Dept Anesthesiol, Pittsburgh, PA 15261 USA Univ Pittsburgh Pittsburgh PA USA 15261 thesiol, Pittsburgh, PA 15261 USA Univ Pittsburgh, Dept Med, Pittsburgh, PA USA Univ Pittsburgh Pittsburgh PA USA ttsburgh, Dept Med, Pittsburgh, PA USA Univ Pittsburgh, Presbyterian Hosp, UPMC, Pittsburgh, PA 15213 USA Univ Pittsburgh Pittsburgh PA USA 15213 p, UPMC, Pittsburgh, PA 15213 USA Univ Pittsburgh, Dept Chem Engn, Pittsburgh, PA 15261 USA Univ PittsburghPittsburgh PA USA 15261 em Engn, Pittsburgh, PA 15261 USA Univ Pittsburgh, McGowan Ctr Artificial Organs, Pittsburgh, PA USA Univ Pittsburgh Pittsburgh PA USA Artificial Organs, Pittsburgh, PA USA Excorp Med Inc, Oakdale, MN USA Excorp Med Inc Oakdale MN USAExcorp Med Inc, Oakdale, MN USA
Titolo Testata:
ASAIO JOURNAL
fascicolo: 5, volume: 47, anno: 2001,
pagine: 471 - 475
SICI:
1058-2916(200109/10)47:5<471:SOIPIC>2.0.ZU;2-D
Fonte:
ISI
Lingua:
ENG
Soggetto:
FULMINANT HEPATIC-FAILURE; ENDOGENOUS RETROVIRUS; ASSIST DEVICE; EXPERIENCE; TRIAL;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
14
Recensione:
Indirizzi per estratti:
Indirizzo: Patzer, JF Univ Pittsburgh, Dept Surg, 1249 Benedum Hall, Pittsburgh, PA 15261 USA Univ Pittsburgh 1249 Benedum Hall Pittsburgh PA USA 15261 1 USA
Citazione:
G.V. Mazariegos et al., "Safety observations in Phase I clinical evaluation of the Excorp Medical Bioartificial Liver Support System after the first four patients", ASAIO J, 47(5), 2001, pp. 471-475

Abstract

A Phase I clinical safety evaluation of the Excorp Medical, Inc, Bioartificial Liver Support System (BLSS) is in progress. Inclusion criteria are patients with acute liver failure of any etiology, presenting with encephalopathy deteriorating beyond Parson's Grade 2. The BLSS consists of a blood pump, heat exchanger to control blood temperature, oxygenator to control oxygenation and pH, bioreactor, and associated pressure and flow alarm systems. Patient liver support is provided by 70-100 g of porcine liver cells housedin the hollow fiber bioreactor. A single support period evaluation consists of 12 hour extracorporeal perfusion with the BLSS sandwiched between 12 hours of pre (baseline) and 12 hours of post support monitoring. Blood chemistries and hematologies are obtained every 6 hours during monitoring periods and every 4 hours during perfusion. Physiologic parameters are monitored continuously. The patient may receive a second treatment at the discretion of the clinical physician. Preliminary evaluation of safety considerations after enrollment of the first four patients (F, 41, acetaminophen induced, two support periods; M, 50, Wilson's disease, one support period; F, 53, acute alcoholic hepatitis, two support periods; F, 24, chemotherapy induced, one support period) is presented. All patients tolerated the extracorporealperfusion well. All patients presented with hypoglycemia at the start of perfusion, treatable by IV dextrose. Transient hypotension at the start of perfusion responded to an IV fluid bolus. Only the second patient required heparin anticoagulation. No serious or unexpected adverse events were noted. Moderate biochemical response to support was noted in all patients. Completion of the Phase I safety evaluation is required to fully characterize thesafety of the BLSS.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/05/20 alle ore 09:48:49