View clinical trials related to Lung Transplantation.
Filter by:Context Cytomegalovirus (CMV) infection is a frequent and potentially severe event in solid organ transplant (SOT) recipients. Most of available treatment display adverse effects that limit their use. Therefore, in case of an infection, it is of primary importance to identify the patients at high risk of severe infection and/or disease, and who ill benefit the most from antiviral therapy. As CMV infection is mainly controlled by cellular immunity, measuring specific anti-CMV T lymphocyte immunity could be an interesting tool for identifying these at-risk individuals. One of these tests is the QuantiFERON-CMV (QF-CMV) assay (QuiagenTM, Courtabœuf, France). Aim of the study The aim of the study is to determine the extent to which the QF-CMV can be use to identify, among SOT recipients with a CMV viremia, those that may not need antiviral therapy. Methods Participation to the study will be proposed to SOT recipients with an asymptomatic CMV infection with a blood viral load between 1,000 and 15,000 IU/mL. The QF-CMV will be performed in included participants, and the result will be given or not to the clinician in charge (according to the attributed group through randomisation). - In the group without result communication, the clinician in charge will determine whether a treatment is needed according to the guidelines and the local practices. - in the group with result communication, the clinician in charge will be advised not to introduce antiviral therapy if the result is positive, and to determine whether a treatment is needed according to the guidelines and the local practices if the result is positive. In the following weeks, the viral load will be monitored, along with creatininemia, cell blood count, and kalemia (to detect antiviral adverse effect). The participants will be sampled: - 5 to 12 days after QF-CMV sampling (V2) ; - 7 to 14 days days after V2 (V3 - between D12 and D26) ; - 7 to 14 days days after V3 (V4 - between D19 and D40) . Endpoints The primary endpoint is the rate of uncontrolled infection 5 to 12 days after QF-CMV sampling, defined as follows: - Blood CMV viral load >10,000 IU/mL [4 log]; - And/or increase in blood viral load ≥0.5 log IU/mL with CV otherwise >5000 IU/mL; - And/or the onset of CMV disease. The secondary endpoint is the is the occurrence antiviral adverse effects (hematoxicity or nephrotoxicity).
The study team developed an uncontrolled donation after circulatory death (uDCD) protocol that preserves lungs for just over 3 hours after death using positive end expiratory pressure (PEEP) and supplemental oxygen. The study will assess lung uDCD program safety by continuous review of operations/clinical records from each case activation and transplantation. Attrition outcomes include rates of initial and continued lung preservation, donation authorization, lung recovery, passing ex-vivo lung perfusion (EVLP) performance testing, and lung transplantation. Planned viability assessments also include macroscopic determination, radiology (X-ray), and fiber optic bronchoscopy before initiating EVLP. We expect ~50% of lungs assessed with EVLP will be transplanted to meet sustainability targets. Safety outcomes include the primary outcome, primary graft dysfunction (PGD) grade III at 72 hours, and secondarily survival one year after transplantation.
This study aims to evaluate the effects of whole-body electrical stimulation (WB-EMS) in the rehabilitation of patients undergoing lung transplantation. This is a randomized clinical trial with patients from the inpatient unit of Dom Vicente Scherer Hospital of Irmandade Santa Casa de Misericórdia from Porto Alegre (ISCMPA) who will be allocated to a control group (which will receive physiotherapy from routine) or intervention group (which will receive physiotherapy from routine and WB-EMS). Interventions with WB-EMS will occur every day from the moment of extubation until hospital discharge (15 sessions per patient). Assessments will be carried out pre-lung transplantation, after extubation, during intervention protocols and at the time of hospital discharge.
Since the first human lung transplantation in 1963, significant advancements in immunosuppressive agents from the mid-1990s have greatly improved the quantity and quality of such procedures. In 2004, a total of 1,815 lung transplantations were globally reported. Patients undergoing this procedure are typically elderly and experience not only impaired lung function but also overall health instability. Despite successful outcomes, postoperative pulmonary complications (PPCs) can lead to serious consequences, including deterioration and fatality. PPCs resulting from lung transplantation may lead to prolonged hospitalization, increased complications, and the need for additional treatment. Various factors, such as age, smoking, pre-existing lung diseases, immunosuppressive drug use, diabetes, hypertension, infections, allergies, and immune disorders, are associated with the development of PPCs. The retrospective analysis of medical records from adult patients who underwent lung transplantation aims to investigate patient characteristics, anesthesia methods, intraoperative tests, and the occurrence of PPCs, with the ultimate goal of analyzing the incidence and risk factors of postoperative respiratory complications and developing a predictive model through machine learning.
Since 1963, lung transplantation progress has surged due to immunosuppressive agent advancements. In 2004, 1,815 global lung transplantations were reported. Elderly recipients face impaired lung function and health instability, leading to potential respiratory complications post-surgery. Postoperative acute renal injury (AKI) can cause temporary or chronic dysfunction, increasing hospitalization, complications, and additional treatment needs. Various factors contribute to postoperative renal dysfunction after lung transplantation, including sustained hypoperfusion, bleeding, heart failure, acute myocardial infarction, pulmonary embolism, sepsis, and medications. Retrospective analysis of adult lung transplant patients' records aims to explore characteristics, anesthesia methods, intraoperative tests, and postoperative acute renal dysfunction, analyzing incidence and risk factors to develop a machine learning predictive model.
Extracorporeal membrane oxygenation (ECMO) is a frequently used extracorporeal support measure during the intraoperative period in lung transplantation. A certain amount of anticoagulation, mainly unfractionated heparin (UFH), is used as part of ECMO support. One of the most common perioperative complications during lung transplantation is bleeding. An inadequately high dose of UFH can increase the risk of bleeding. In this study, the investigators hypothesised that a lower dose of UFH would decrease the risk of nonsurgical bleeding complications during lung transplantation and would not pose an increased risk of thrombotic complications for patients or ECMO circuits.
The goal of this clinical trial is to learn about the safety and effectiveness of LAM-001 in patients who have developed bronchiolitis obliterans syndrome (BOS), a form of chronic rejection, after lung transplantation. The main questions it aims to answer are: - Is LAM-001 safe in these patients? - Is LAM-001 effective in slowing BOS progression? Participants will: - Be randomly assigned to inhale either LAM-001 or placebo (a look-alike substance that contains no active drug) daily for 48 weeks - Attend 10 study visits (mixture of in-person and telehealth) over the 48 week period - Undergo pulmonary function testing, bronchoscopy, lab testing, and physical examination - Submit weekly home spirometry monitoring Researchers will compare participants assigned to LAM-001 versus placebo to see if LAM-001 is safely tolerated and to assess the effectiveness of LAM-001 on slowing BOS progression.
Demonstrate the relationship between dd-cfDNA levels and HLA antibodies in blood transplant recipient and Demonstrate the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from lung transplants.
The aim of this investigation is to compare two different anti-coagulation strategies in clinical lung transplantation where lung implantations are all routinely done on veno-arterial (VA) extracorporeal membrane oxygenation (ECMO) support at the investigators' institution. No heparinization (Zero-Hep) will be compared to standard low-dose heparinization (Standard). Traditionally, the Vienna group has used a standard low-dose heparin protocol with unfractionated heparin (UFH) administered as a bolus upon ECMO cannulation. With heparin-coated tubing and intraoperative ECMO flow never falling below 1 L/min, the likelihood of thromboembolic events is believed to be negligible. To date, the investigators have not experienced any thromboembolic events during intra-operative ECMO use. On the other hand, the use of UFH entails an increased risk for bleeding, so it follows that avoidance of additional heparin may be beneficial. Generally, risks and benefits of heparinization during these short procedures have not yet been thoroughly analyzed. This study will investigate the feasibility of running heparin free VA-ECMO support during clinical lung transplantation and its effect on clinical outcomes and inflammatory response comparing 40 patients receiving a standard dose of heparin versus 40 patients receiving placebo in a randomized, double-blind study design.
TRIGGER 1 is a previous study that evaluate the immunological risk of pregnancy in women with lung transplants in France, whose pregnancy has ended between January 1, 2012 and December 31, 2021. The primary endpoint is the occurrence of humoral rejection with a year after pregnancy. TRIGGER 2 aims to evaluate the risk of humoral rejection if there are common antigens between the child and the lung donor. We will collect HLA typing from children to compare them to the HLA typing of the mother, the lung donor and the antibodies produced if there are. Thus, it will help us to suggest recommendations to limit the immunological risk of pregnancy for lung transplant women. Lung transplantation is the treatment of choice of terminal chronic respiratory failure, such as cystic fibrosis and pulmonary hypertension. Young female patient of childbearing age are concerned. For many years, given the risk of maternal and fetal complications, pregnancies were not recommended. Studies on large cohorts of transplanted patients, particularly kidney transplanted patients, have made it possible to study the risks of maternal, obstetrical and neonatal complications. A few studies have been published in lung transplantation on small numbers of patients. However, these publications reporting on the fate of pregnancies in cohorts of lung transplant patients do not mentioned the immunological risk, with in particular the absence of studies on the risk of humoral rejection, appearance of anti-HLA (Human Leukocyte Antigens) antibodies (Ac) and the possible appearance of anti-HLA Ac directed against the donor (donor specific antibody, DSA). TRIGGER 1 is a previous study, whose main objective is to evaluate the immunological risk of pregnancy in women with lung transplants (mono-, bi-, or cardiopulmonary) in France, whose pregnancy has ended between January 1, 2012 and December 31, 2021. The primary endpoint is the occurrence of humoral rejection within 1 year after pregnancy. For this study TRIGGER2, we will collect the HLA typing of the children for pregnancies that resulted in the birth of a child. Thus, we will be able to compare the HLA typing of the children with the HLA typings of the mother and the lung donor, and the antibodies produced by the mother. The primary endpoint is to evaluate the risk of humoral rejection if there are common HLA antigens between the child and the lung donor.