Lung Transplant

This research focuses on kidney transplant patients to collect blood samples and clinical data for developing a non-invasive test that detects donor-derived cell-free DNA (dd-cfDNA) to assess the condition of transplanted kidneys. The study is prospective and multicenter, involving participants who have had a kidney transplant and are undergoing an indication biopsy. The goal is to improve monitoring of the transplanted organ's status. Participants will provide whole blood samples at the time of their indication biopsy, before the biopsy procedure itself. Additionally, leftover de-identified retrospective genomic DNA (gDNA) samples from the kidney donors will be collected for paired analysis. This approach helps researchers study dd-cfDNA in a real-world transplant population. Participants will be involved through blood sample collection and clinical data gathering during their biopsy visits. Researchers will monitor the detection of donor-derived cell-free DNA in whole blood over an 18-month period. The study involves no investigational treatments, focusing on observation and sample analysis. Participation duration and follow-up details align with the biopsy schedule and sample collection requirements.

Researchers are evaluating the effects of extracorporeal photopheresis (ECP) therapy in patients who have undergone lung transplantation and have subclinical antibody-mediated rejection with persistent donor-specific antibodies (dnDSAs). The study aims to determine whether ECP can reduce the mean fluorescence intensity (MFI) of these antibodies, and assess its impact on acute cellular rejection (ACR), clinical antibody-mediated rejection (AMR), chronic lung allograft dysfunction (CLAD), infections, survival, adverse events, and other immunological markers. The trial will randomly assign 80 patients into two groups of 40 each. One group will receive ECP treatment starting within one week after randomization, consisting of two-day treatment cycles every two weeks for the first two months, followed by monthly two-day cycles for six months. The control group will be observed without receiving active treatment, representing the current standard of care. Researchers will compare outcomes between the groups, including immunophenotyping, miRNA profiling, cytokine expression, gene expression of peripheral blood mononuclear cells, and proteomic analysis. Participants will be monitored over six months to evaluate changes in dnDSA levels and clinical outcomes such as rejection episodes, infections, survival, and adverse effects. Assessments will include laboratory tests and immunological profiling to understand the mechanisms of ECP. This study is sponsored by the Medical University of Vienna and involves patients who are clinically stable with persistent dnDSAs and no signs of graft dysfunction after bilateral lung transplantation.

This research study evaluates whether participating in 12 sessions of Latin dance can improve wellbeing in adults who have received a lung transplant. The study focuses on areas such as balance, fear of movement, anxiety, depression, and lung function as measured by spirometry. The goal is to understand how this behavioral intervention may support psychological and physical health after lung transplant. Participants who received a single or double lung transplant at Mayo Clinic Florida since January 1, 2020, will take part in open Latin dance sessions over a 12-week period. Each session includes a warm-up with music, two choreographed dances, and a cooldown routine. This intervention is observed as a behavioral treatment without masking or placebo comparison. During the study, participants will be assessed at the start and end of the 12 weeks for changes in anxiety, depression, fear of movement (using the Tampa Kinesophobia Scale), gait, and lung function (Forced Expiratory Volume in one second). The study monitors wellbeing through these functional measures and psychological assessments to evaluate the impact of Latin dance on lung transplant recipients.

This research aims to compare chronic pain outcomes following different robotic-assisted thoracic surgery (RATS) techniques used for pulmonary resections in patients with lung tumors. These surgeries are important for treating lung neoplasms, with approaches tailored to tumor size and location. Minimally invasive surgeries like video-assisted thoracic surgery (VATS) have reduced acute pain but chronic pain remains a concern. The study evaluates three RATS methods: the transthoracic approach (RATS-TT), the "out of cage" technique (RATS-OTC) that avoids intercostal nerve injury, and a hybrid method (RATS-TTH) used at CHUM. Participants will have pulmonary resection surgery using one of the three RATS techniques. RATS-TT uses intercostal trocars for instruments and specimen removal, RATS-OTC avoids intercostal access by using subcostal or subxiphoid ports, and RATS-TTH combines intercostal instrument access with out-of-cage specimen extraction to reduce nerve trauma. The study observes pain at 3 and 6 months post-surgery to assess chronic pain incidence. These approaches are compared to understand their effects on persistent pain after surgery. Participants will be followed up at 3 and 6 months after surgery to assess persistent postoperative pain, including chest pain at rest or with coughing. Pain will be evaluated by patient response, and additional assessments include neuropathic pain components, overall recovery, analgesic use, opioid consumption, hospital stay length, residual pain intensity, and presence of dysesthesia. The study collects data on these outcomes to better understand long-term pain following different surgical techniques for lung tumor removal.

Researchers are evaluating two different techniques for performing bilateral lung transplantation: the off-pump method and the use of venoarterial extracorporeal membrane oxygenation (VA ECMO). This trial aims to determine which technique results in lower rates of primary graft dysfunction, a serious complication after lung transplantation. Previous studies have shown conflicting results about which approach may be better, so this prospective randomized trial seeks to provide clearer answers. Participants will undergo lung transplantation using either the off-pump technique or the VA ECMO technique, both delivered as part of standard care. The off-pump procedure involves general anesthesia, lung removal, implantation, reperfusion, and ventilation without the use of ECMO. In contrast, the VA ECMO approach includes ECMO cannulation and support during the surgery before decannulation and closure. The trial compares these two procedures directly. Throughout the study, participants will be monitored closely for primary lung graft dysfunction at 48 to 72 hours and mortality at 90 days. Additional assessments include blood transfusions, chest tube output, bleeding complications, incidence of air embolism, stroke, pneumonia, dialysis need, transplant rejection, and length of mechanical ventilation and hospital stay. These comprehensive evaluations will help researchers understand the outcomes and safety of each transplantation method over the follow-up period extending to 90 days after surgery.

Researchers are evaluating the effectiveness and safety of belumosudil compared with placebo in adults with chronic lung allograft dysfunction (CLAD) who are at least one year after a bilateral lung transplant. This phase 3, double-blind, randomized, placebo-controlled study includes participants of both genders aged 18 years and older who continue to have worsening CLAD despite azithromycin therapy. The study is conducted across multiple countries and centers to gather comprehensive data on treatment outcomes. Participants will be randomly assigned to receive either 200 mg of belumosudil orally once daily or a placebo, both alongside azithromycin and the standard immunosuppression regimen. The treatment period lasts up to 26 weeks for those not entering the open-label extension (OLE) and up to 52 weeks for those who do. Participants entering the long-term OLE will continue treatment and study visits every 12 weeks according to protocol. Participants will attend up to 10 visits during the initial phase or up to 16 visits if they enter the OLE. Assessments include lung function tests such as forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), 6-minute walk distance, and quality of life questionnaires like the Saint George Respiratory Questionnaire (SGRQ). Researchers will monitor changes in these measures, track adverse events, and evaluate the time to CLAD progression, re-transplantation, or death. Study participation may continue for several months with ongoing safety monitoring.

Researchers are evaluating the safety and feasibility of lung transplants from blood group A2 donors to blood group O recipients. This study aims to increase the donor pool for blood group O lung transplant candidates, who often face longer wait times and higher mortality on the waitlist. It is the first prospective study worldwide to assess ABO-incompatible lung transplants in this way. The intervention involves lung transplant surgery using lungs from blood group A2 donors transplanted into blood group O recipients who have low anti-A antibody levels and a negative virtual crossmatch at the time of transplant. The study monitors the recipients closely after surgery to assess immune response and transplant success. Participants will be monitored through various evaluations including antibody levels on post-operative days 5 or 12, primary graft dysfunction grading in the first three days, and assessment for rejection or infection over the following years. Long-term follow-up up to 10 years will evaluate graft function, chronic lung problems, infections, malignancies, and survival outcomes. The total participation time varies depending on individual follow-up and outcomes.

Researchers are investigating the relationship between kidney oxygen levels during lung transplant surgery and the risk of kidney failure shortly after the operation. This observational study focuses on acute kidney injury, which affects more than half of lung transplant patients and sometimes requires kidney support treatments. The study aims to see if near-infrared spectroscopy (NIRS), a non-invasive method measuring kidney tissue oxygen, can predict early postoperative kidney failure by monitoring kidney hypoxia during surgery. Participants undergoing lung transplantation will have their kidney oxygen saturation measured using NIRS throughout the surgery. This technique has been used in heart surgeries but not extensively studied in lung transplants. The researchers will calculate a renal hypoxia index combining the depth and duration of low kidney oxygen levels during the operation to evaluate its predictive value for kidney failure. During the study, patients will be monitored closely for kidney function and complications for five days after surgery. Outcomes such as early acute kidney failure, use of kidney support therapies, survival status, changes in kidney function tests, and lung graft health will be recorded. This monitoring will help determine if intraoperative kidney oxygen monitoring can guide prevention strategies and improve outcomes after lung transplantation.

Researchers are evaluating the safety and effectiveness of using preoperative aerosol inhalation of Indocyanine Green (ICG) solution to improve thoracoscopic surgery for congenital lung malformations in children. This study focuses on children aged between 3 months and 14 years who have been diagnosed with congenital lung malformations, aiming to help surgeons accurately identify and remove affected lung tissue. Before surgery, children undergo pulmonary ventilation function evaluation and enhanced lung CT scans. Approximately 30 minutes before surgery, they inhale an ICG solution dissolved in saline at a dose of 0.5 mg/kg. During surgery, a fluorescence thoracoscope is used to clearly differentiate normal lung tissue from diseased tissue by fluorescence staining. The lesion boundaries are marked, and lung tissue is carefully dissected using specialized surgical tools. After removing the lesion, the surgical area is examined for bleeding or air leaks, followed by chest drainage tube placement. Participants are followed up 3 to 6 months after surgery with outpatient visits including pulmonary CT scans and lung function tests. Measurements such as tidal volume, inhalation/exhalation time ratio, peak time ratio, and peak volume ratio are compared before and after surgery. Researchers also monitor the rate of residual disease at 3 months and hospital stay length up to 14 days to assess outcomes and safety.

Researchers are gathering detailed information about patients who have experienced severe bleeding that required a massive transfusion, such as after serious injury, surgery, or childbirth. This observational study collects and analyzes data to better understand how often these events occur, what happens to patients, and how blood transfusions are used in these situations. The study is conducted by Monash University and includes data from multiple hospitals in Australia and New Zealand. The study uses electronic methods to collect existing clinical data from hospital databases, including transfusion records and patient demographics. This information is securely linked and analyzed to provide insights into transfusion practices and patient outcomes after critical bleeding events. The registry includes data from over 6,000 patients across 25 sites, covering various clinical settings such as trauma, surgery, obstetrics, and gastrointestinal bleeding. Participants in this study are adults who experienced critical bleeding and received at least five units of red blood cells within four hours. The study monitors outcomes such as mortality within 30 days after the bleeding event. Data linkage with national death indexes and other registries helps provide comprehensive outcome measurements. The study allows ongoing collection and analysis of data to improve transfusion policies and patient care practices over time.