Platelet Aggregation in the Diagnosis of Acute Graft Rejection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Martin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult patients (≥18 years)
primary kidney transplantation
living / deceased donor kidney transplantation
ability and consent to participate
Disqualifiers
non-adult patients
secondary / tertiary kidney transplantation
antiplatelet therapy
patients unable to provide informed consent
Trial population
Patients with chronic kidney disease who underwent kidney transplantation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: kidney transplant recipients - Protocol Biopsy Cohort
Group B: kidney transplant recipients - Indication Biopsy Cohort
Trial outcomes
Primary outcomes
1
To compare changes in platelet aggregation in patients before and after kidney transplantation
Platelet aggregation measured by optical aggregometry before kidney transplantation will be compared with platelet aggregation measured at 3 and 12 months after transplantation to assess changes in platelet function over time.
Time frame
Pre-transplant baseline; 3 months post-transplant; 12 months post-transplant2
To evaluate the changes in platelet aggregation in the diagnosis of humoral/cellular graft rejection (at the time of biopsy due to graft dysfunction)
Platelet aggregation will be assessed at the time of an indication biopsy performed for graft dysfunction and compared between patients with biopsy-proven humoral or cellular rejection and those without rejection. The aim is to determine whether altered platelet aggregation is associated with acute graft rejection identified on histopathology.
Time frame
At the time of indication biopsy (any time after transplantation)3
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
Flow-cytometric P-selectin (CD62-P) expression on platelets and soluble P-selectin levels in plasma will be measured before and after kidney transplantation and at the time of protocol or indication biopsy. These values will be compared between patients with and without biopsy-proven rejection to assess whether P-selectin can serve as a reliable marker of platelet activation associated with acute graft injury and support the development of a non-invasive diagnostic approach.
Time frame
Pre-transplant baseline; at 3- and 12-month protocol biopsies; and at the time of any indication biopsy after kidney transplantationSponsors and contacts
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Source ClinicalTrials.gov