Haemodialysis Alters Hypercoagulability of Blood in Dialysis Patients

NCT ID: NCT07098676

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-20

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ai Peng

OTHER

Sponsor Role lead

Responsible Party

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Ai Peng

Director of the department of Nephrology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Changbin Li

Role: STUDY_DIRECTOR

Shanghai 10th People's Hospital

Locations

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

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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SHYS-IEC-5.0/22K162/P01

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAT-t-PAIC

Identifier Type: -

Identifier Source: org_study_id

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