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OpenTrials
Enrolling by Invitation

NCT Number: NCT07098676

Haemodialysis Alters Hypercoagulability of Blood in Dialysis Patients

Primary Objective:

To develop a thrombotic event risk assessment model integrating serum biomarkers (TM, TAT, t-PAIC, PIC) with clinical data, systematically compare its predictive performance across healthy populations, vascular surgery patients with acute thrombosis, and dialysis patients, and evaluate its predictive advantages over the Padua Prediction Score and D-dimer.

Secondary Objective:

To investigate the expression profiles of these four thrombotic biomarkers in different populations and their associations with thrombotic event types and clinical contexts (e.g., duration of dialysis, anticoagulation regimens), identifying independent risk factors and underlying mechanisms to provide a scientific foundation for stratified thrombotic risk management and personalized intervention strategies.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200272, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • dialysis patients: The inclusion criteria included patients with end-stage chronic kidney disease (eGFR≤15 mL/(min·1.73m²)) who had been on regular dialysis at the hospital for at least three months healthy volunteer:aged between 18 and 85 years; (2) without any clinically diagnostic severe diseases including but not limited to a tumor, diabetes, cardiovascular, renal, nervous, digestive and mental disorders Diagnostic Criteria for Thrombosis: (1) Confirmed Imaging Evidence: Definitive visualization of a thrombus using imaging modalities such as ultrasonography (e.g., Doppler ultrasound for deep vein thrombosis), computed tomography (CT) pulmonary angiography, or magnetic resonance imaging (MRI) venography. (2) Consistent Clinical Presentation Supported by Imaging: A clinical picture suggestive of thrombosis (e.g., limb swelling, pain, or respiratory distress) corroborated by positive imaging findings. (3) Laboratory and Clinical Correlation: Elevated levels of a laboratory marker, such as D-dimer, combined with imaging evidence of thrombosis, and exclusion of alternative causes of symptoms (e.g., conditions listed in pregnancy registries or other differential diagnoses).

Exclusion criteria

  • dialysis patients: (1) hemodialysis patients with no recent history of major surgical conditions or other diseases that could influence hemagglutination; (2) patients not on regular dialysis for at least three months; (3) patients who did not provide informed consent or complete the Paruda scoring form.

Thrombosis: (1) blood samples collected more than 24 hours after the thrombotic event; (2) blood samples taken while patients were using small-molecule heparin or other medications that could alter blood coagulation status

Treatment and study plan

Primary outcomes

  1. thrombosis outcome in dialysis patients

    Time frame: 1 years

    • Incidence of radiologically confirmed thrombosis Definition: Thrombus definitively visualized by ultrasonography, CT pulmonary angiography, or MRI venography.
    • Incidence of clinically suspected thrombosis with imaging support Definition: Clinical presentation (e.g., limb swelling, pain, respiratory distress) with positive imaging findings.
    • Incidence of laboratory-supported thrombosis with imaging evidence Definition: Elevated D-dimer levels + positive imaging findings + exclusion of alternative diagnoses.

Sponsors and collaborators

Lead sponsor

Ai Peng

Other

Registry information

Acronym: TAT-t-PAIC

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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