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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Patients applied
Trial Officials
Changbin Li
Study Director
Shanghai 10th People's Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported