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1.Screening

Investigator signature

徐丽云

1.Inclusion Criteria

Age 18-80 years

Yes

Diagnosis of end-stage renal disease and a preference for hemodialysis

Yes

Initial arteriovenous fistula creation on the surgical side of the upper extremity, meeting vascular criteria outlined in Figure 3, including a patent return vein, a cephalic vein diameter ≥ 2 mm, a postoperative cannulation length of ≥10 cm, radial artery diameter ≥ 1.5 mm, and a distance between t

Yes

Expected survival duration >12 months

Yes

Informed consent and willingness to participate in clinical follow-up

Yes

2.Exclusion Criteria

Those currently enrolled in another clinical trial involving drugs or medical devices

No

Pregnant or breastfeeding women

No

Patients with an ejection fraction (EF) <30% as assessed by echocardiography

No

Patients with severe pathological changes in other organs, including the cardiovascular and cerebrovascular systems, within the past month.

No

Patients with a life expectancy of less than one year

No

Patients with central venous lesions on the operative side, including a history of central venous catheterization, breast cancer surgery, cardiac pacemaker implantation, or other central venous

No

Patients diagnosed with severe infections

No

Patients with arterial stenosis on the operative side.

No

2.Baseline

Investigator signature

徐丽云

1.General information

date of birth

1962-08-12

sex

height

167 CM

weight

63 Kg

2.Physical examination

blood pressure

168/80 mmHg

temperature

36.9

heart rate

111 次/分

3.Primary disease

Primary diseases

糖尿病肾病

4.Complication

complication

肾性贫血

5.Other medical history

Is blood pressure normal?

abnormal

smoking history

NO

Drinking history

No

allergic history

Yes

6.Vascular access history

History of central venous catheterization

No

History of vascular access surgery

No VA history

Surgical history of other affected VA

No

7.Preoperative ultrasound vascular assessment

Preoperative vascular ultrasound evaluation

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10.Coagulation Function Tests

coagulation funtion tests

/uploads/patrecord/11788/param512691/029536ff-5c27-4da1-8ebd-2c417a845749.pdf

11.Serum Liver and Renel Function Tests

serum liver and renel function tests

/uploads/patrecord/11788/param512692/42dae617-fcff-45c0-98da-502b7389e583.pdf

13.Heat Function Examination

Cardiac function test

/uploads/patrecord/11788/param512694/ba29b96a-4b5d-4317-9d70-eb08c1fc5b2c.pdf

14.Pregnancy tests

pregnancy tests

No

Pregnancy test results

3.Intraoperative
1.Surgery information

date of surgery

2025-04-23

Operation start time

10:50

End of operation time

11:45

anesthesia method

limb

3.Intraoperative medication

4.Post-operative management (infrared, anticoagulation, etc.)

4.Follow-up 1
1.Visit status

Visit status

2.Follow-up method

Follow-up method

3.Follow-up date

Follow-up date

4.HD
4.4.1、Deprecate or not

abandon

4.4.2、First dialysis time

First dialysis time

4.4.3、Pumps control blood flow

Pumps control blood flow

4.4.4、Is HD successful?

Is HD successful?

5.US results

US results

6.Intervention or not

Intervention

Intervention

7.Hospitalization

Hospitalization

Cause of hospitalization

8.Death

death

death time

5.Follow-up 2
1.Visit status

visit status

2.Follow-up method

Follow-up method

3.Follow-up date

Follow-up date

4.Intervetion or not

Intervetion or not

Intervention

5.Hospitalization

Hospitalization

Cause of hospitalization

6.Death

Death

cause of death

6.Follow-up 3
1.Visit status

Visit status

2.Follow-up method

Follow-up method

3.Follow-up date

Follow-up date

4.HD
6.4.1、Deprecate or not

Deprecate or not

6.4.2、HD or not

HD or not

6.4.3、First dialysis time

First dialysis time

6.4.4、Pumps control blood flow

PCDF

6.4.5、Is HD successful?

Is HD successful?

5.US results

US results

6.Intervetion or not

Intervention or not

intervention method

7.Hospitalization

Hospitalization

Cause of hospitalization

8.Death

death

cause of death

7.Follow-up 4
1.Visit status

Visit status

2.Follow-up method

Follow-up method

3.Follow-up date

Follow-up date

4.HD
7.4.1、Deprecate or not

Deprecate or not

7.4.2、HD or not

HD or not

7.4.3、First dialysis time

First dialysis time

7.4.4、PCBF

PCBF

7.4.5、Is HD successful?

Is HD successful?

5.US results

US results

6.Intervetion or not

Intervention or not

Intervention method

7.Hospitalization

Hospitalization

Cause of hospitalization

8.Death

death

cause of death

8.ADR/ADE management system
1.ADR/ADE 1

Name of adverse event

incident description

date

Adverse event characteristics

Severity Degree

Relationship with surgical procedure

take action

prognosis

end time

SAE or not

2.ADR/ADE 2
9.Scheme deviation
1.Scenarios deviate from the stage in which they occur

Stage

2.Scheme deviation type

Informed consent issue

Violation of inclusion/exclusion criteria

Failure to follow protocol for examination and treatment

Follow-up was not conducted according to the study process time window

AE/SAE does not meet reporting requirements

loss to follow-up

other

10.Study completed/discontinued early
11.Institutions
1.Longhua Hospital Shanghai University of Traditional Chinese Medicine
2.Suzhou Research Center of Medical School, Suzhou Hospital, Affiliated Hospital of Medical School, Nanjing University
3.Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
4.Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
5.The First Affiliated Hospital of Sun Yat-sen University
6.The First Affiliated Hospital of Dalian Medical University
7.The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
8.Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
9.China-Japan Friendship Hospital
10.Affiliated Hospital of Jiangsu University
11.Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China
12.Suzhou Municipal Hospital, The affiliated Suzhou Hospital of Nanjing Medical University
13.The First Affiliated Hospital, Zhejiang University School of Medicine
14.Guangdong provincial hospital of Chinese Medicine Hainan Hospital
15.Mianyang Central Hospital
16.Jinling Hospital, Nanjing University School of Medicine
17.Affiliated Cancer Hosptial of Guizhou Medical University
18.NO.2 People's Hospital of Fuyang City
19.Suzhou Hospital of Integrated Traditional Chinese and Western Medicine
20.The First Affiliated Hospital of Zhengzhou University
21.Taizhou Hospital of Zhejiang Province
22.People's Hospital of Suzhou New District
23.The second people's hospital, Wuhu
24.Anqing Shengtong Nephropathy Hospital
25.The Second Affiliated Hospital of Anhui Medical University
26.Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Science), Southern Medical University
27.The First Hospital of Hebei Medical University
28.The NO.1 Affiliated Hospital of Kunming Medical University
29.Beijing Haidian Hospital (Haidian Section, Peking University Third Hospital)
12.Researchers