Actively Recruiting

Age: 18Years +
All Genders
ID07275541

Platelet Aggregation in the Diagnosis of Acute Graft Rejection

Led by University Hospital, Martin · Updated on 2025-12-10

60

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether changes in platelet function can serve as non-invasive markers for detecting acute rejection in kidney transplant patients. This pilot observational study focuses on adult kidney transplant recipients, examining platelet aggregation and activation markers to understand their role in early kidney graft injury and immune response. The goal is to support diagnosis of acute cellular or antibody-mediated rejection alongside traditional biopsy methods. The study measures platelet function using optical aggregometry, flow cytometry for P-selectin expression, and soluble P-selectin levels. Two groups are observed: patients undergoing routine protocol biopsies at 3 and 12 months post-transplant, and patients with signs of graft dysfunction who receive indication biopsies. Alongside platelet assessments, the study collects biochemical, immunological, and donor-specific antibody data to correlate with biopsy results. Participants undergo platelet testing before transplant and at scheduled biopsy times or when graft dysfunction is suspected. Researchers review platelet activation profiles, histopathology, and clinical outcomes to assess their potential as non-invasive diagnostic tools. The study involves longitudinal monitoring of renal function, immunosuppression levels, and metabolic parameters to provide a comprehensive understanding of graft health over time.

CONDITIONS

Brief Title

Platelet Aggregation in the Diagnosis of Acute Graft Rejection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 years or older
  • Primary kidney transplantation recipients
  • Recipients of living or deceased donor kidneys
  • Ability and willingness to provide informed consent
Not Eligible

You will not qualify if you...

  • Patients under 18 years of age
  • Secondary or tertiary kidney transplantation recipients
  • Patients currently on antiplatelet therapy
  • Patients unable to provide informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 12 months post-transplant and beyond as needed

Participants who have received a kidney transplant are monitored through protocol biopsies and clinical assessments to evaluate platelet aggregation and activation markers at scheduled time points and during suspected graft dysfunction.

Visits at pre-transplant baseline, 3 months, 12 months post-transplant, and at any time of indication biopsy due to graft dysfunction

Trial Site Locations

Total: 1 location

1

Transplant-Nephrology Department, University Hospital Martin

Martin, Slovakia, 03601

Actively Recruiting

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Research Team

T

Timea Blichova, MD

P

Patricia Kleinova, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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