Haemodialysis Alters Hypercoagulability of Blood in Dialysis Patients

NCT07098676 | Enrolling By Invitation

• 2 other identifiers: TAT-t-PAICSHYS-IEC-5.0/22K162/P01
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Individuals (Controls); Vascular Surgery Patients With Acute Thrombosis; Dialysis Patients

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

Outcome Measures

Primary Outcomes (1)

• thrombosis outcome in dialysis patients

  1. Incidence of radiologically confirmed thrombosis Definition: Thrombus definitively visualized by ultrasonography, CT pulmonary angiography, or MRI venography. 2. Incidence of clinically suspected thrombosis with imaging support Definition: Clinical presentation (e.g., limb swelling, pain, respiratory distress) with positive imaging findings. 3. Incidence of laboratory-supported thrombosis with imaging evidence Definition: Elevated D-dimer levels + positive imaging findings + exclusion of alternative diagnoses.

  1 years

Study Arms (3)

healthy volunteer

(1) 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

Vascular surgery patients with acute thrombosis

Inclusion criteria (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 were: (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.

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. Exclusion criteria were: (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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 volunteers Diagnostic Criteria for Thrombosis: (1) Confirmed Imaging Evidence; (2) Consistent Clinical Presentation Supported by Imaging: A clinical picture suggestive of thrombosis corroborated by positive imaging findings; (3) Laboratory and Clinical Correlation

You may not qualify if:

• 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

Sponsors & Collaborators

• Ai Peng: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200272, China

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Changbin Li

  Shanghai 10th People's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the department of Nephrology

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: August 1, 2025
• Study Start: November 20, 2024
• Primary Completion: May 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)