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Идёт набор NCT07275541

Platelet Aggregation in the Diagnosis of Acute Graft Rejection

— Наблюдательное Platelet Aggregation Kidney Transplant Rejection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Platelet Aggregation, Kidney Transplant Rejection. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Словакия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The study titled "Platelet Aggregation in the Diagnosis of Acute Graft Rejection" is a pilot observational study evaluating whether alterations in platelet function can serve as non-invasive markers of acute rejection in kidney transplant recipients. Platelet aggregation is assessed using optical aggregometry, flow-cytometric P-selectin (CD62-P) expression, and soluble P-selectin levels before kidney transplantation and at the time of protocol biopsies performed at 3 and 12 months after kidney transplantation. Patients with suspected graft dysfunction undergoing indication biopsy are also included. Platelet activation markers are correlated with histopathological findings, donor-specific antibodies, metabolic parameters, and clinical outcomes. The goal is to determine whether platelet activation profiles can identify acute cellular or antibody-mediated rejection and contribute to the development of a non-invasive diagnostic tool.

Подробное описание

Platelets play a key role not only in hemostasis but also in inflammation and immune responses. Their activation, characterized by adhesion, integrin-mediated aggregation, thromboxane A₂ production, and surface expression of markers such as P-selectin, contributes to interactions with T lymphocytes and amplification of immune signaling. Emerging evidence suggests that platelet activation may participate in early mechanisms of kidney graft injury. Studies have demonstrated platelet accumulation in glomerular and peritubular capillaries during antibody-mediated rejection, likely mediated by donor-specific antibodies and endothelial activation via von Willebrand factor. Elevated platelet activation markers such as PF4 and P-selectin have also been associated with T-cell-mediated rejection.

This pilot study investigates whether changes in platelet aggregation and platelet activation markers can serve as non-invasive indicators of acute kidney allograft rejection. Platelet function is measured using optical aggregometry, flow cytometry of P-selectin (CD62-P), and soluble P-selectin levels. These parameters are correlated with histological findings from protocol biopsies at 3 and 12 months post-transplant, as well as from indication biopsies performed for suspected rejection. The study includes adult kidney transplant recipients monitored longitudinally and a cohort of patients with graft dysfunction requiring indication biopsy. Concurrent assessments include renal function, donor-specific antibodies, levels of immunosupression (tacrolimus), metabolic parameters, and imaging. By comparing platelet activation profiles with biopsy-proven rejection, the study aims to determine whether platelet-based biomarkers can support early, non-invasive detection of cellular or antibody-mediated allograft injury and complement traditional biopsy-based diagnostics.

Первичные конечные точки

  • To compare changes in platelet aggregation in patients before and after kidney transplantation [Срок оценки: Pre-transplant baseline; 3 months post-transplant; 12 months post-transplant]
  • To evaluate the changes in platelet aggregation in the diagnosis of humoral/cellular graft rejection (at the time of biopsy due to graft dysfunction) [Срок оценки: At the time of indication biopsy (any time after transplantation)]
  • To investigate the use of P-selectin as a potential marker of platelet activation in the diagnosis of acute graft rejection as part of a non-invasive investigation [Срок оценки: Pre-transplant baseline; at 3- and 12-month protocol biopsies; and at the time of any indication biopsy after kidney transplantation]

Критерии участия

Критерии включения

  • adult patients (≥18 years)
  • primary kidney transplantation
  • living / deceased donor kidney transplantation
  • ability and consent to participate

Критерии исключения

  • non-adult patients
  • secondary / tertiary kidney transplantation
  • antiplatelet therapy
  • patients unable to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Словакия · 1 центр
  • Transplant-Nephrology Department, University Hospital Martin — Martin

Идентификаторы

NCT: NCT07275541 · TNO_AGRE · UK/3248/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗