A multicentre randomised controlled trial to compare the efficacy of ex-vivo normothermic machine perfusion with static cold storage in human liver transplantation

2018 ◽  
Author(s):  
David Nasralla ◽  
David Nasralla ◽  
Mohammed Zeeshan Akhtar ◽  
Ally Bradley ◽  
Andrew Butler ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Randomised Controlled Trial ◽  
Cold Storage ◽  
Human Liver ◽  
Ex Vivo ◽  
Controlled Trial ◽  
Machine Perfusion ◽  
Normothermic Machine Perfusion ◽  
Randomised Controlled

scholarly journals Hypothermic oxygenated machine perfusion (HOPE) for orthotopic liver transplantation of human liver allografts from extended criteria donors (ECD) in donation after brain death (DBD): a prospective multicentre randomised controlled trial (HOPE ECD-DBD)

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017558 ◽  
Author(s):  
Zoltan Czigany ◽  
Wenzel Schöning ◽  
Tom Florian Ulmer ◽  
Jan Bednarsch ◽  
Iakovos Amygdalos ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Randomised Controlled Trial ◽  
Brain Death ◽  
Orthotopic Liver Transplantation ◽  
Controlled Trial ◽  
Control Group ◽  
Machine Perfusion ◽  
Clinical Series ◽  
Donation After Brain Death ◽  
Randomised Controlled

IntroductionOrthotopic liver transplantation (OLT) has emerged as the mainstay of treatment for end-stage liver disease. In an attempt to improve the availability of donor allografts and reduce waiting list mortality, graft acceptance criteria were extended increasingly over the decades. The use of extended criteria donor (ECD) allografts is associated with a higher incidence of primary graft non-function and/or delayed graft function. As such, several strategies have been developed aiming at reconditioning poor quality ECD liver allografts. Hypothermic oxygenated machine perfusion (HOPE) has been successfully tested in preclinical experiments and in few clinical series of donation after cardiac death OLT.Methods and analysisHOPE ECD-DBD is an investigator-initiated, open-label, phase-II, prospective multicentre randomised controlled trial on the effects of HOPE on ECD allografts in donation after brain death (DBD) OLT. Human whole organ liver grafts will be submitted to 1–2 hours of HOPE (n=23) via the portal vein before implantation and are going to be compared with a control group (n=23) of patients transplanted after conventional cold storage. Primary (peak and Δ peak alanine aminotransferase within 7 days) and secondary (aspartate aminotransferase, bilirubin and international normalised ratio, postoperative complications, early allograft dysfunction, duration of hospital and intensive care unit stay, 1-year patient and graft survival) endpoints will be analysed within a 12-month follow-up. Extent of ischaemia–reperfusion (I/R) injury will be assessed using liver tissue, perfusate, bile and serum samples taken during the perioperative phase of OLT.Ethics and disseminationThe study was approved by the institutional review board of the RWTH Aachen University, Aachen, Germany (EK 049/17). The current paper represent the pre-results phase. First results are expected in 2018.Trial registration numberNCT03124641.

Ex-vivo gene therapy of human vascular bypass grafts with E2F decoy: the PREVENT single-centre, randomised, controlled trial

The Lancet ◽  
1999 ◽  
Vol 354 (9189) ◽  
pp. 1493-1498 ◽  
Author(s):  
Michael J Mann ◽  
Anthony D Whittemore ◽  
Magruder C Donaldson ◽  
Michael Belkin ◽  
Michael S Conte ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Randomised Controlled Trial ◽  
Ex Vivo ◽  
Controlled Trial ◽  
Bypass Grafts ◽  
Single Centre ◽  
Vascular Bypass ◽  
Ex Vivo Gene Therapy ◽  
Vascular Bypass Grafts ◽  
Randomised Controlled

scholarly journals Prospective, single-centre, randomised controlled trial to evaluate the efficacy and safety of ischaemia-free liver transplantation (IFLT) in the treatment of end-stage liver disease

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e035374
Author(s):  
Changjun Huang ◽  
Shanzhou Huang ◽  
Yunhua Tang ◽  
Qiang Zhao ◽  
Dongping Wang ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Liver Disease ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Single Centre ◽  
Donor Liver ◽  
End Stage Liver Disease ◽  
Randomised Controlled ◽  
End Stage

IntroductionDuring conventional liver transplantation (CLT), ischaemia-reperfusion injury (IRI) is inevitable and is associated with complications such as early allograft dysfunction (EAD), primary non-function and ischaemic-type biliary lesions. We have established a novel procedure called ischaemia-free liver transplantation (IFLT). The results from a pilot study suggest that IFLT might prevent IRI and yield better transplant outcomes than CLT. The purpose of this study was to further assess the efficacy and safety of IFLT versus CLT in patients with end-stage liver disease.Methods and analysisThis is an investigator-initiated, open-label, phase III, prospective, single-centre randomised controlled trial on the effects of IFLT in patients with end-stage liver disease. Adult patients (aged 18–75 years) eligible for liver transplantation will be screened for participation in this trial and will be randomised between the IFLT group (n=34) and the CLT group (n=34). In the IFLT group, the donor liver will be procured, preserved and implanted with continuous normothermic machine perfusion (NMP). In the CLT group, the donor liver will be procured after a fast cold flush, preserved in 0°C–4°C solution and implanted under hypothermic and hypoxic conditions. Patients in both groups will be managed according to the standard protocol of our centre. The primary end point is the incidence of EAD after liver transplantation. Intraoperative and postoperative parameters of donor livers and recipients will be observed and recorded, and postoperative liver graft function, complications and recipient and graft survival will be evaluated. After a 12-month follow-up of the last enrolled recipient, the outcomes will be analysed to evaluate the safety and efficacy of IFLT versus CLT in patients with end-stage liver disease.Ethics and disseminationThe protocol was reviewed and approved by the Ethics Committee of The First Affiliated Hospital of Sun Yat-sen University. The findings will be disseminated to the public through conference presentations and peer-reviewed scientific journals.Trial registration numberChiCTR1900021158.

scholarly journals First human liver transplantation using a marginal allograft resuscitated by normothermic machine perfusion

2015 ◽  
Vol 22 (1) ◽  
pp. 120-124 ◽  
Author(s):  
Thamara Perera ◽  
Hynek Mergental ◽  
Barney Stephenson ◽  
Garrett R. Roll ◽  
Hentie Cilliers ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Human Liver ◽  
Machine Perfusion ◽  
Normothermic Machine Perfusion

Tacrolimus versus microemulsified ciclosporin in liver transplantation: the TMC randomised controlled trial

The Lancet ◽  
2002 ◽  
Vol 360 (9340) ◽  
pp. 1119-1125 ◽  
Author(s):  
JG O'Grady ◽  
A Burroughs ◽  
P Hardy ◽  
D Elbourne ◽  
A Truesdale
Keyword(s):  
Liver Transplantation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals Development of ex vivo normothermic perfusion as an innovative method to assess pancreases after preservation

2021 ◽  
Vol 2 (4) ◽  
Author(s):  
Ann Ogbemudia
Keyword(s):  
Cold Storage ◽  
Ex Vivo ◽  
Gas Analysis ◽  
Machine Perfusion ◽  
Assessment Strategy ◽  
Hypothermic Machine Perfusion ◽  
Normothermic Perfusion ◽  
Pancreas Preservation ◽  
Normothermic Machine Perfusion ◽  
Lactate Levels

Ann Ogbemudia, Julien Branchereau (Joint first authors), Gabriella Hakim, Fungai Dengu, FaysalEl-Gilani, John Mulvey, Kaithlyn Rozenberg, Thomas Prudhomme, Letizia Lo Faro, James Hunter,Paul Johnson, Rutger Ploeg and Peter Friend   Objective Static cold storage (SCS) is the standard method for pancreas preservation but does not facilitate objective organ assessment prior to transplantation. Normothermic machine perfusion (NMP) has been used to test other abdominal and thoracic organs’ function and viability in transplantation settings. Our aim was to develop a NMP protocol specific for pancreases and then investigate its potential as an organ assessment strategy. Method 8 porcine pancreases were procured in conditions replicating donation after circulatory death with warm ischaemia time of 25 minutes. After 3 hours of static cold storage (SCS) the pancreases were divided into 3 experimental groups 1) the feasibility group (n=2) that underwent 2.5 hours of NMP 2) the SCS group (n = 2) that underwent an additional 6 hours of SCS prior to assessment on NMP for an hour and 3) the Oxygenated Hypothermic Machine Perfusion (oxyHMP) group (n = 4) that underwent 6 hours of oxyHMP followed by 1-hour assessment on NMP. The NMP protocol used autologous, leucodepleted blood delivered at a mean arterial pressure of 40mmHg with a temperature of 37oC. At timed intervals during NMP, perfusate samples were collected for gas analysis and perfusion parameters were recorded. Results The feasibility group was used to develop the NMP protocol and demonstrated stable perfusion parameters throughout NMP. Compared to the SCS group the oxyHMP group demonstrated better average perfusion characteristics with lower resistances, higher flow rates, lower mean lactate levels and physiological pH. The oxyHMP group maintained normal macroscopic appearances during NMP. At the end of NMP the SCS group had an average 32% weight increase compared to the oxyHMP group that were found to have a 17% weight reduction. Conclusion Normothermic machine perfusion of whole pancreases is feasible after cold preservation and potentially useful as an assessment strategy. Furthermore, it demonstrated that oxygenated HMP may be beneficial for pancreas preservation compared to SCS.

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