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Transplantation clinical trials

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NCT ID: NCT04257747 Recruiting - Clinical trials for Magnetic Resonance Imaging

Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI

FLOWHAND
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Allotransplants of vascularized composite tissues are subject to chronic vascular rejection, which can lead to graft loss. Currently, no imaging technique allows a reproducible quantitative exploration of the arterial trees of the hand, and therefore a satisfactory monitoring of transplants. Since 2014, flow MRI has been applied to the analysis of small-calibre arteries by the Image Processing Team at the Amiens-Picardie University Hospital. Between 2015 and 2017, several acquisitions were made in 3 patients who received facial allotransplantation, and the team recently developed a flow MRI protocol dedicated to the study of arterial trees in the hand. The main objective is to measure vascular flows of radial, ulnar and interdigital arterial trees in normal (healthy volunteers) and pathological situations (patients with radial forearm flap reconstruction and patients with hand allotransplantation) using the specifically developed flow MRI protocol.

NCT ID: NCT03920735 Recruiting - Critical Illness Clinical Trials

Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients

Start date: March 15, 2017
Phase:
Study type: Observational

The analysis of a cohort of consecutive non-selected patients from the Strasbourg University Hospital, and therefore representative of the real life, will allow better identifying the risk factors for these infections (by comparison with a cohort of patient with similar conditions of immunosuppression and no infection) and improving the diagnosis and therapeutic management. The primary objective is to identify prognosis factors affecting survival in patients with opportunistic infections

NCT ID: NCT03581019 Enrolling by invitation - Transplantation Clinical Trials

Uterus Transplantation From Deceased Donor - Gothenburg III

Start date: June 17, 2018
Phase: N/A
Study type: Interventional

Deceased donor uterus transplantation will be offered to patients that have either been excluded from Gothenburg II because of donor criteria or because of early graft failure in Gothenburg I and II

NCT ID: NCT03533049 Completed - Pediatric ALL Clinical Trials

mHealth Family Self-Management

myFAMI
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This innovative research will address a gap in the literature involving the evaluation of the impact of an individualized family-centered mHealth application to enhance daily post-discharge communication following pediatric transplant. This proposal lays the foundation for future research with myFAMI (self-management intervention) at multiple pediatric transplant centers and builds the science from which to consider post discharge monitoring and decrease cost of care in other pediatric chronic illness populations.

NCT ID: NCT03180359 Completed - Transplantation Clinical Trials

Vaccines Immunogenicity in Renal, Hepatic, Cardiac or Pulmonary Transplanted Children

COVAGREF
Start date: January 1, 2016
Phase: N/A
Study type: Interventional

Thanks to improved surgical techniques, postoperative management and immunosuppressive therapies, an increasing number of children benefit from renal, hepatic, cardiac and pulmonary transplantation. Infection is a significant cause of mortality and morbidity in these patients, particularly due to vaccine-preventable diseases. Vaccination is one of the effective means of reducing infection-related mortality in these particularly vulnerable children. It is mostly well-tolerated, but all the more effective as it is performed early before transplantation, at best during a dedicated consultation, according to a vaccine scheme adapted to the immunocompromised child. In the almost constant absence of clinical efficacy data in populations of immunocompromised individuals, vaccine efficacy is most often indirectly estimated by immunogenicity, using protective correlates obtained by extrapolation in immunocompetent individuals. Primary objective: To estimate the immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation, using serological titers measurements before and after a vaccine injection for: influenza, pneumococcus, chicken pox, measles, tetanus, hepatitis A and hepatitis B. These serological titers will be compared to correlates of protection existing for each valency. The evolution of serological titers will be described during the first year. The vaccination will be carried out within the routine care, according to the recommendations. Secondary objectives: - describe and quantify the vaccination status of patients - describe the vaccination coverage of their entourage - evaluate the tolerance and efficacy of vaccines

NCT ID: NCT03114436 Completed - Critical Illness Clinical Trials

National Observational Study of Clinical Practices in Deceased Organ Donation

CanadaDONATE
Start date: August 31, 2016
Phase:
Study type: Observational

This is a 1-year national prospective cohort study that observes the medical management of consented deceased organ donors at hospitals across Canada with a high volume of deceased donation.

NCT ID: NCT03083769 Completed - Transplantation Clinical Trials

Functional Genetic Variants Affecting Tacrolimus Trough Levels and Side Effects in Chinese Renal Transplantation.

Start date: January 1, 1998
Phase:
Study type: Observational

The purpose of this study is to determine whether functional genetic variants can affect tacrolimus dose corrected trough levels and associate with the side effects in Chinese renal transplant recipients.

NCT ID: NCT03076151 Completed - Transplantation Clinical Trials

Pharmacokinetic Study of Adoport® (Tacrolimus) in Patients With de Novo Kidney Transplantation

IMPAKT
Start date: February 12, 2018
Phase: Phase 4
Study type: Interventional

Tacrolimus is a calcineurin inhibitor widely used for the prevention of allograft rejection in solid organ and bone marrow transplantation. It is characterized by a narrow therapeutic index and large inter-individual pharmacokinetic variability. Adoport® is an immediate-release formulation of tacrolimus, to be administered twice daily. Because of a narrow therapeutic window and a better correlation between pre-dose level and effects than between dose and effect, therapeutic drug monitoring (TDM) based on trough whole blood tacrolimus concentrations is recommended for Adoport®. TDM helps to minimize the risk of acute rejection and the occurrence of adverse effects (mainly nephrotoxicity and, to a lesser extent, neurotoxicity). As reported in a consensus document from a consortium of European experts on tacrolimus TDM, the interdose area-under-the curve (AUC0-12h) is expected to be the best marker of tacrolimus exposure. However, tacrolimus monitoring based on full AUC0-12h is difficult to set up in routine, due to clinical constraints and the necessity of multiple samples. Calculation of the AUC0-12h using Bayesian estimation and a limited sampling strategy, i.e. a few blood samples collected during the early phase post-dose would represent an elegant solution, as already done for other tacrolimus formulations. Furthermore, the pharmacokinetics (PK) of tacrolimus is influenced by a single nucleotide polymorphism within intron 3 of cytochrome P450 3A5 (CYP3A5). Patients who carry at least one CYP3A5*1 allele are considered to be CYP3A5 expressors (about 12% of the Caucasian population, Hapmap project) and thus require a 1.5 to 2-fold higher starting dose than CYP3A5*3/*3 carriers to reach the predefined target exposure early after transplantation. Although this polymorphism showed no impact on the performance of the Bayesian estimators previously developed for other tacrolimus formulation, the patient status for CYP3A5*3 will be considered in this pharmacokinetic study as a potential covariate in, or confounding factor of, the PK model. Specifically, owing to a 12% frequency in the White European population, about 4 patients carriers of the CYP3A5*1 allele are expected in this study; the performance of the PK model and Bayesian estimator developed will be specifically evaluated in this subgroup.

NCT ID: NCT02949492 Terminated - Liver Diseases Clinical Trials

Low-dose IL-2 for Treg Expansion and Tolerance (LITE)

LITE
Start date: December 12, 2017
Phase: Phase 4
Study type: Interventional

Regulatory T cells (Tregs) suppress cytopathic immune responses and inhibit transplant rejection. Our goal is to exploit the Treg suppressive properties to induce transplantation tolerance. In contrast to effector T cells, Tregs constitutively express the high affinity IL-2 receptor, which makes them exquisitely sensitive to very low-doses of IL-2. We propose here to conduct a phase IV clinical trial in which we will test the capacity of low-dose IL-2 to promote the selective expansion of endogenous Tregs in liver transplant recipients at the time immunosuppressive drugs are being discontinued. We expect this will promote Treg accumulation within the transplanted liver, shift the balance between effector T cells and Tregs, and facilitate the development of operational tolerance in patients unlikely to reach this state spontaneously. We expect the trial to start shortly after the initiation of the project and to provide robust evidence on the efficacy of IL-2 within 47 months.

NCT ID: NCT02939365 Withdrawn - Transplantation Clinical Trials

Precision Medicine Offers Belatacept Monotherapy

PROBE
Start date: February 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the safety and feasibility of converting patients to Belatacept monotherapy (receiving just one immunosuppression drug), and to see what percentage of those patients can be safely converted to once every 8 week administration of Belatacept. Belatacept has been approved by the Food and Drug Administration (FDA) for kidney transplant recipients.