Normothermic Oxygenated Perfusion (NMP) Viability Testing Before Transplantation of Discarded Livers. An Open Label, Non-randomized, Prospective, Single Arm Trial

Liver transplantation (LT) is a highly effective treatment for end-stage liver disease and early-stage primary liver cancer. As such, the demand for donor livers greatly exceeds supply; in 2021 in France, 12.9% of patients on the waitlist either died or were delisted for worsening of their condition.
However a substantial number of perfectly viable organs are wrongly discarded based on a highly subjective assessment as the level of acceptance varies widely depending on the physician's judgement.
The idea of using Normothermic Machine Perfusion (NMP) not only to preserve the liver graft but also for selection purposes is a concept that has been already investigated. A few trials have analyzed the value of normothermic perfusion to assess rejected liver grafts.
Several teams demonstrated that NMP provides a tool to assess organ viability pre-transplantation as the liver is able to maintain an almost physiological metabolism.
These preliminary results came from small samples, 45% of which originated from donation after circulatory death (DCD). They need confirmation in a larger sample of organs from donors with brainstem death (DBD), adapted to the French liver allocation system.
This trial will reproduce and confirm the results of the previous studies in order to establish viability testing as the de facto method for high-risk or rejected grafts. It will also validate existing viability markers so as to define a new standard for viability testing using NMP.

开始日期2025-06-15

申办/合作机构

Centre Hospitalier Universitaire de Rennes

DRKS00034228

/ SuspendedN/AIIT

Hyperspectral imaging (HSI) for non-invasive quantification of ureteral perfusion in the context of living kidney donation - an intraoperative method for predicting the risk of ureterovesical complications

开始日期2025-02-18

申办/合作机构-

NCT06652919

/ RecruitingN/AIIT

Development and Validation of Materials for the Pharmaceutical Care of Organ Transplant Recipients in Community Pharmacy: Survey on the Evaluation of Medication Information Leaflets for Organ Transplant Patients

The aim of this study is to collect feedback from organ transplant patients or their caregivers/relatives on the medication information leaflets we've developed, using a questionnaire, and to adjust the content to better meet the specific needs of this unique patient group.

开始日期2024-11-06

申办/合作机构

Westfälische Wilhelms-Universität Münster

100 项与移植相关的疾病相关的临床结果

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100 项与移植相关的疾病相关的转化医学

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项与移植相关的疾病相关的文献（医药）

2025-07-01·Journal of Clinical and Experimental Hepatology

Impact of Perioperative Serum Sodium Levels on Outcomes Following Living Donor Liver Transplantation

Article

作者: Rajakumar, Akila ; Paulin, Susan ; Sam, Amal Francis ; Rela, Mohamed ; Jothimani, Dinesh ; Rammohan, Ashwin

Background & objectivesPreoperative hyponatremia has been shown to be associated with poor outcomes post-liver transplantation. We analyzed the impact of preoperative hyponatremia and perioperative sodium (Na) changes on outcomes following adult living donor liver transplantation.MethodsAfter obtaining clearance from Institutional ethical Committee, a retrospective review of electronic database and medical records of all adult patients who underwent LDLT between January 2019 and September 2022 was done and relevant perioperative data were collected.ResultsThe study cohort of 520 recipients was divided into four groups based on preoperative serum Na levels in mmol/L; 12 patients (2.3%) in Group A (<125); 66 patients (12.6%) in Group B (125-129); 216 patients (41.5%) in Group C (130-135) and 226 patients (43.4%) in Group D (136-145). MELD score, preoperative AKI, SBP, intraoperative ascites volume, volume of packed blood cells (PRC), other blood products and 25% albumin were significantly associated with the degree of hyponatremia. No other outcomes including mortality was associated any grade of hyponatremia. The delta sodium on postoperative day 1 was largest in Group A. The level of Na rise post-transplant on POD1 had an inverse correlation with preoperative Na levels [ r (520) -0.6, P < 0.001]. High delta sodium was not associated with neurological complications in this cohort. Group A patients had higher incidence of postoperative AKI requiring dialysis followed by groups B, C and D. Eighty-six (16.5%) patients had large delta-Na of >10 mmol/L. On univariate analysis, low pretransplant Na (<130mEq/L), preoperative AKI, SBP, higher MELD and ascitic volumes, intraoperative transfusions of PRC, blood products and 25% albumin, early allograft dysfunction and need for dialysis, were associated with larger delta-Na. On multivariate analysis, preoperative Na levels ≤130 mmol/L, intraoperative ascites and PRC transfusion were found to be independent risk factors for a large delta-Na.ConclusionHyponatremia, being a factor associated with liver disease, might not by itself contribute to poor survival when the deleterious effects of large delta changes can be avoided. The results from this study reinforces the fact that with a cautious perioperative approach, patients with hyponatremia can be transplanted safely in LDLT settings.

2025-05-01·Ultrasound in Medicine & Biology

Quantitative Analysis of Contrast-Enhanced Ultrasound Images of Brain-Dead Donor Livers: Prediction of Early Allograft Dysfunction

Article

作者: Wu, Xiaodong ; Cai, Jinzhen ; Yang, Zizhen ; Xu, Chuanshen ; Wang, Jianhong ; Zhang, Di ; Sun, Jiao ; Ren, Xiuyun

OBJECTIVETo determine the CEUS parameters that predict the likelihood of postoperative EAD.METHODSClinical and imaging data for 75 pairs of donors and recipients collected between September 2022 and July 2023 were retrospectively analyzed. Subjects were divided into those with early allograft dysfunction (EAD) and those without EAD. The liver parenchyma was selected as the region of interest to plot the CEUS time-intensity curve. CEUS parameters were compared between the two groups.RESULTSPeak intensity, area under the curve (AUC), and cholinesterase values were significantly lower in the EAD group than in the non-EAD group. The hepatic arterial-portal arrival interval (APAI) and aspartate aminotransferase level were significantly higher in the EAD group. Multivariate logistic analysis identified the APAI to be an independent risk factor for EAD (odds ratio 0.755; 95% confidence interval 0.577-0.989; p = 0.041). Receiver-operating characteristic curve analysis showed that the prediction probability P, which represents a combination of CEUS and clinical data, was best able to predict EAD (AUC 0.802; 95% confidence interval 0.679-0.926; p < 0.0001). Comparison of the AUC for prediction probability P and each single parameter identified statistically significant differences between the predicted probability P and aspartate aminotransferase and cholinesterase values (p = 0.042 and p = 0.020, respectively).CONCLUSIONA longer APAI can be used as a biomarker to predict EAD after brain-dead donor liver transplantation. CEUS could be a valuable tool for assessment of donor livers and identifying recipients potentially at risk of developing postoperative EAD.

2025-05-01·Liver Transplantation

Prolonged time from cross-clamp until normothermic machine perfusion start is associated with an increased risk of early allograft dysfunction following DCD liver transplant

Article

作者: Croome, Kristopher P. ; Heimbach, Julie K. ; Mao, Shennen ; Lee, Charles ; Taner, C. Burcin ; Aqel, Bashar ; Mathur, Amit K.

There is a paucity of data on the impact of cold ischemia time before the initiation of normothermic machine perfusion (NMP), particularly in more susceptible organs such as livers from donation after circulatory death (DCD) donors. The present analysis aimed to investigate the impact of prolonged time from cross-clamp until NMP start on early allograft dysfunction and other peri–liver transplant (LT) outcomes. All DCD LT performed and placed on NMP at Mayo Clinic Arizona, Florida, and Rochester from January 2022 to March 2024 were included. The decision was made a priori to divide the population into 2 groups based on terciles: typical cross-clamp to on-pump time (lower 2 terciles) versus prolonged cross-clamp to on-pump time (upper tercile; >2 h 45.6 min). Three hundred eighty-four DCD LT undergoing NMP met the inclusion criteria. The rate of early allograft dysfunction was significantly higher in the prolonged cross-clamp to on-pump group (51.2%) compared to the typical cross-clamp to on-pump group (37.6%) (p = 0.01). The prolonged cross-clamp to on-pump group also had higher rates of acute kidney injury and the number of packed red blood cells transfused during LT. No significant difference in ischemic cholangiopathy (2.4% vs. 3.1%; p = 0.68) or graft survival at 12 months was seen between the prolonged cross-clamp to on-pump and typical cross-clamp to on-pump group, respectively. Following cross-clamp, DCD liver grafts should be placed on the NMP pump as quickly as is safely and logistically possible. In cases where delays are unavoidable, such as waiting for biopsy results or liver reallocation with another center, acceptable results can still be achieved, and therefore, livers with prolonged times should still be used.

项与移植相关的疾病相关的新闻（医药）

2024-12-18

·PRNewswire

Bridge to Life Acquires VitaSmart™ Hypothermic Oxygenated Machine Perfusion System from Medica S.p.A.

Ownership Strengthens Bridge to Life's Position in Organ Preservation and Solidifies Enterprise Value CHICAGO, Dec. 18, 2024 /PRNewswire/ -- Bridge to Life Ltd., a leader in organ preservation solutions and perfusion technology, has acquired the VitaSmart™ Hypothermic Oxygenated Machine Perfusion System from Medica S.p.A.. The agreement also includes exclusive global trademark rights and the ability to register the VitaSmart™ name worldwide. This acquisition marks a significant milestone in Bridge to Life's efforts to advance transplant medicine. Over 5,0001 successful liver perfusions have been conducted globally using Hypothermic Oxygenated Perfusion (HOPE) in combination with the VitaSmart™ system, demonstrating its effectiveness in organ preservation. "We are thrilled to now own the VitaSmart™ Hypothermic Oxygenated Machine Perfusion System, a proven technology that has empowered European clinicians to implement HOPE protocols with ease and efficiency," said Don Webber, CEO and President of Bridge to Life Ltd. "The system's user-friendly design and minimal monitoring requirements make it a game-changer for organ preservation." Webber highlighted that the company is in the final stages of preparing its FDA submission for VitaSmart, targeting the first quarter of 2025. "The results from the one-year patient follow-up on our pivotal U.S. study are complete and we are extremely impressed with the clinical outcomes, including demonstrated statistical superiority between study and control arms for the primary endpoint (Early Allograft Dysfunction) and shorter length of hospital stay following transplantation. This acquisition positions us to expand access to this transformative technology for U.S. transplant centers, organ procurement organizations, and, most importantly, patients awaiting viable livers. Full ownership of VitaSmart™ enhances our enterprise value and strengthens our ability to meet global demand." This strategic move aligns with Bridge to Life's mission to improve transplantation outcomes and save more lives. About Medica S.p.A. Medica S.p.A., headquartered in the biomedical district of Mirandola, Italy, is an integrated Italian biomedical and MedTech group with a strong international footprint. The company is committed to developing products of the highest technological innovation for the purification of blood and water. About Bridge to Life Ltd Bridge to Life Ltd is a market leader in organ preservation solutions, offering premier products such as Belzer UW®, EasiSlush® and the VitaSmart2 Machine Perfusion System. With a strong focus on product quality, innovation and accessibility, the company serves and partners with leading Transplant Centers and Organ Procurement Offices globally. 1 Number of perfusions is based on liver perfusions sets sold through October 31, 2024 2 VitaSmart™ is CE Marked and available for sale in several markets outside of the United States. VitaSmart™ is not approved for sale in the US. SOURCE Bridge to Life, Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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2024-12-16

·SYNAPSE

Bridge to Life™ Acquires VitaSmart™ Hypothermic Oxygenated Machine Perfusion System from Medica S.p.A.

Ownership Strengthens Bridge to Life™’s Position in Organ Preservation and Solidifies Enterprise Value Chicago, December 18, 2024 – Bridge to Life™ Ltd., a leader in organ preservation solutions and perfusion technology, has acquired the VitaSmart™ Hypothermic Oxygenated Machine Perfusion System from Medica S.p.A.. The agreement also includes exclusive global trademark rights and the ability to register the VitaSmart™ name worldwide. This acquisition marks a significant milestone in Bridge to Life™’s efforts to advance transplant medicine. Over 5,000 successful liver perfusions have been conducted globally using Hypothermic Oxygenated Perfusion (HOPE) in combination with the VitaSmart™ system, demonstrating its effectiveness in organ preservation. “We are thrilled to now own the VitaSmart™ Hypothermic Oxygenated Machine Perfusion System, a proven technology that has empowered European clinicians to implement HOPE protocols with ease and efficiency,” said Don Webber, CEO and President of Bridge to Life™ Ltd. “The system’s user-friendly design and minimal monitoring requirements make it a game-changer for organ preservation.” Webber highlighted that the company is in the final stages of preparing its FDA submission for VitaSmart™, targeting the first quarter of 2025. “The results from the one-year patient follow-up on our pivotal U.S. study are complete and we are extremely impressed with the clinical outcomes, including demonstrated statistical superiority between study and control arms for the primary endpoint (Early Allograft Dysfunction) and shorter length of hospital stay following transplantation. This acquisition positions us to expand access to this transformative technology for U.S. transplant centers, organ procurement organizations, and, most importantly, patients awaiting viable livers. Full ownership of VitaSmart™ enhances our enterprise value and strengthens our ability to meet global demand.” This strategic move aligns with Bridge to Life™’s mission to improve transplantation outcomes and save more lives.

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