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Search / Trial NCT07098676

Haemodialysis Alters Hypercoagulability of Blood in Dialysis Patients

Launched by AI PENG · Jul 31, 2025

Trial Information

Current as of November 08, 2025

Enrolling by invitation

Keywords

Thrombin Thrombomodulin Complex (Tm) Thrombin Antithrombin Complex (Tat) Plasmin α2 Plasmin Inhibitor Complex (Pic) Tissue Plasminogen Activator Inhibitor Complex (T Paic) Tat/Pic Ratio Diagnosis

ClinConnect Summary

This study is watching how four blood clotting markers, along with regular clinical information, can predict the chance of blood clots forming in three groups: healthy adults, people on dialysis, and patients who have recently had a clot after vascular surgery. It is an observational study, which means researchers will observe and collect data without giving any new treatments. They plan to enroll about 900 people and will compare how well the biomarker-based model predicts clots across the groups, checking if it works better than some existing tools like D-dimer tests or the Padua score.

Who can join: adults aged 18 to 85. In particular, dialysis patients must have end-stage kidney disease with very low kidney function and have been on regular dialysis for at least 3 months. Healthy volunteers are 18–85 years old and do not have major qualifying illnesses. Patients with acute thrombosis must have imaging-confirmed clots (or a clinical picture supported by imaging). Participants will have blood draws to measure the four biomarkers and will provide clinical information; the study will follow participants to see if and when clots occur, especially over about a one-year period. The trial is being conducted at Shanghai 10th People’s Hospital and is currently enrolling by invitation, with results expected later in 2026.

Gender

ALL

Eligibility criteria

  • 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

About Ai Peng

Ai Peng is a forward-thinking clinical trial sponsor dedicated to advancing medical research through innovative methodologies and cutting-edge technology. With a focus on enhancing patient outcomes, Ai Peng specializes in designing and managing clinical trials that leverage artificial intelligence and data analytics to streamline processes and improve trial efficiency. Committed to ethical practices and regulatory compliance, the organization collaborates with healthcare professionals and research institutions to bring new therapies to market, ultimately contributing to the betterment of global health.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Changbin Li

Study Director

Shanghai 10th People's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported