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 organs 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 efficacy and safety of belumosudil compared with placebo in adult participants who have chronic lung allograft dysfunction CLAD after bilateral lung transplantation. This Phase 3, randomized, double-blind, placebo-controlled study focuses on participants at least one year after their transplant, who show progressive CLAD despite treatment with azithromycin. The study is multinational, multicenter, and parallel-group, aiming to assess lung function changes over time. Participants will receive either 200 mg of oral belumosudil once daily or a matching placebo, both alongside azithromycin and standard immunosuppression care. The study includes a treatment period lasting up to 26 weeks for those not entering the open-label extension OLE and up to 52 weeks for those entering the OLE but not the long-term extension. For participants in the long-term OLE, treatment and study visits continue every 12 weeks as specified. During the study, participants will attend up to 10 visits if not entering the OLE, or up to 16 visits if entering the OLE but not the long-term phase. Assessments include lung function tests such as forced expiratory volume in 1 second FEV1 and forced vital capacity FVC, 6-minute walk distance, and quality of life questionnaires. Safety is monitored by recording adverse events. The total study duration may be up to 31 weeks for some and up to 57 weeks for others, with ongoing monitoring for those in the long-term extension.

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.

Postoperative pain after video-assisted thoracoscopic surgery VATS remains a significant challenge despite using multiple pain relief methods. This clinical trial is designed to evaluate whether adding a 5 mcghour transdermal buprenorphine patch to the usual pain management plan can reduce pain in adults undergoing unilateral VATS. The study is randomized, triple-blind, and placebo-controlled to ensure objective assessment. It is conducted at Clnica Dvila in Santiago, Chile, with 90 participants planned. Participants will be randomly assigned to receive either a transdermal buprenorphine patch or a placebo patch before surgery, in addition to standard multimodal analgesia. The buprenorphine patch is a long-acting opioid partial agonist, and the study compares its effect on postoperative pain against placebo. The patches are applied preoperatively and participants continue with their usual multimodal analgesic regimen. The randomization is computer-generated and masked to participants, researchers, and assessors. During the study, participants will have their pain intensity measured using a Numeric Rating Scale at 24, 48, and 72 hours, and 7 days after surgery. Secondary outcomes monitored include opioid rescue medication use, incidence of nausea, vomiting, itching, urinary retention, and length of hospital stay up to 30 days. Participants will be closely followed to assess these outcomes and safety throughout the postoperative period.

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 mgkg. 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, inhalationexhalation 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.