Platelet Aggregation in the Diagnosis of Acute Graft Rejection

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• adult patients (≥18 years)

• primary kidney transplantation

• living / deceased donor kidney transplantation

• ability and consent to participate

Locations
Other Locations
Slovakia
Transplant-Nephrology Department, University Hospital Martin
RECRUITING
Martin
Contact Information
Primary
Timea Blichova, MD
tc@unm.sk
+421434203184
Backup
Patricia Kleinova, MD
tc@unm.sk
+421434203184
Time Frame
Start Date: 2024-11-26
Estimated Completion Date: 2027-11-26
Participants
Target number of participants: 60
Treatments
kidney transplant recipients - Protocol Biopsy Cohort
Adult kidney transplant recipients undergoing routine protocol biopsies at 3 and 12 months post-transplant, regardless of clinical graft function. Platelet aggregation, flow-cytometric P-selectin expression, soluble P-selectin levels, and biochemical and immunological parameters are collected at each time point.~Findings from platelet function testing are subsequently correlated with the histopathological results of the protocol biopsy, including the presence or absence of subclinical rejection.
kidney transplant recipients - Indication Biopsy Cohort
Kidney transplant recipients presenting with clinical signs of graft dysfunction-such as rising serum creatinine, increasing proteinuria, or abnormal ultrasound findings or with newly positive donor-specific antibodies (DSA) detected by Luminex testing, prompting the need for an indication biopsy due to suspected acute rejection. At the time of biopsy, platelet aggregation testing, P-selectin markers, comprehensive biochemical parameters, and DSA levels are collected. This cohort represents patients with clinically or immunologically apparent graft injury, allowing comparison with protocol-biopsied patients, including those with subclinical or biopsy-confirmed rejection.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Martin

This content was sourced from clinicaltrials.gov