Healthy Individuals (Controls)TAT-t-PAICNCT07098676
Haemodialysis Alters Hypercoagulability of Blood in Dialysis Patients
An observational study of Healthy Individuals (Controls) and Vascular Surgery Patients With Acute Thrombosis, run by Ai Peng at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals (Controls), Vascular Surgery Patients With Acute Thrombosis, Dialysis Patients
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200272
About this study
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.
Read more
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
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
thrombosis outcome in dialysis patients
- 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.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start20 Nov 2024
- Primary completion30 May 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Individuals (Controls)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ai Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ai Peng, Shanghai 10th People's Hospital
- Investigators
- Changbin Li, Study director, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098676
- Sponsor's protocol ID
- TAT-t-PAIC
- Other IDs
- SHYS-IEC-5.0/22K162/P01
- Acronym
- TAT-t-PAIC
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodialysis Alters Hypercoagulability of Blood in Dialysis Patients
- ClinicalTrials.gov ID
- NCT07098676
- Acronym / sponsor ID
- TAT-t-PAIC / TAT-t-PAIC
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Ai PengUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
thrombosis outcome in dialysis patients
Time frame: 1 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Changbin Li study director
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Individuals (Controls) and Vascular Surgery Patients With Acute Thrombosis, run by Ai Peng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thrombosis outcome in dialysis patients (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.