ThrombosisEASOATNCT04164693
Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula
A study testing Low molecular weight heparin and non anticoagulant therapy group in people with Thrombosis, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Many guidelines at home and abroad advocate that arteriovenous fistula should be the first choice of permanent vascular access, but it is easy to form thrombus in a short time after arteriovenous fistula molding, resulting in internal fistula stenosis or occlusion. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- What is being tested?
- Low molecular weight heparin and non anticoagulant therapy group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- After AVF formation or balloon dilation surgery, there were no significant signs of oozing or bleeding at the surgical incision and operative site observed within 12-24 hours.
- The patient is willing to accept short-term anticoagulant therapy after the surgery, bear related risks, and sign an informed consent form.
- The patient is willing to cooperate with this study, undergo data collection related to the research, and relevant clinical examinations.
Who cannot join
- Age >80 years;
- Concurrent hematologic diseases that can affect coagulation function;
- Concurrent comorbidities that can affect the patient's bleeding or coagulation functions, such as liver cirrhosis;
- Concurrent active bleeding disorders, such as active gastrointestinal ulcers or active lupus;
- History of major organ bleeding (e.g., intracranial or gastrointestinal) or surgery within the past six months;
- Unwillingness to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Many guidelines at home and abroad advocate that arteriovenous fistula should be the first choice of permanent vascular access, but it is easy to form thrombus in a short time after arteriovenous fistula molding, resulting in internal fistula stenosis or occlusion. In this study, the investigators plan to screen the patients with arteriovenous fistula in the blood purification center of our hospital. Through the study design of random grouping and open label, the investigators will discuss the use of low molecular weight heparin or warfarin to prevent thrombosis in a short period of time after arteriovenous fistula operation. According to the research results, the investigators will understand efficacy and safety of short-term postoperative anticoagulant therapy to prevente thrombosis in arterovenous fistula.
- Conditions
- Thrombosis
- Being tested
- Low molecular weight heparin, non anticoagulant therapy group
- Keywords
- manitenance hemodialysis, arteriovenous fistula, anticoagulant therapy, fistula function, bleeding risk
- Medical subject headings
- Thrombosis, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low molecular weight heparinDrug
Also called warfarin sodium tablets
patients began to use low molecular weight heparin or warfarin sodium tablets.
non anticoagulant therapy groupOther
no anticoagulant was used after operation.
| Study group | Role | What they receive |
|---|---|---|
| anticoagulant group | Experimental | Patients in the anticoagulant group received low-dose subcutaneous injection of low molecular weight heparin for prevention of AVF thrombosis, starting 12-24 hours after surgery. For patients weighing less than 80kg, enoxaparin sodium 4000IU was administered once daily, while for those weighing over 80kg, enoxaparin sodium 4000IU was administered every 12 hours. After discharge, these patients were switched to oral low-dose warfarin for anticoagulation, with a daily dose of 1.25mg (half tablet) on dialysis days, and 2.5mg/day on non-dialysis days. Patients with significantly excessive body weight may be considered for a daily dose of 2.5mg, with a total treatment duration of 4 weeks. Receives: Drug: Low molecular weight heparin |
| control group | Other | Patients in the control group did not receive anticoagulants postoperatively, but both groups routinely received antiplatelet therapy. Receives: Other: non anticoagulant therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow of arteriovenous fistula
Blood flow of arteriovenous fistula during hemodialysis from 6 months after operation
Measured: up to 12 months
arteriovenous fistula dysfunction or occlusion
The proportion of arteriovenous fistula dysfunction or occlusion
Measured: up to 12 months
Active bleeding events
such as,bleeding of surgical wound, intracranial, digestive tract and urinary tract, ecchymosis and ecchymosis of skin.
Measured: up to 12 months
arteriovenous fistula dysfunction or occlusion
The time of arteriovenous fistula dysfunction or occlusion
Measured: up to 12 months
AVF Maturation Failure AVF Maturation Failure AVF Maturation Failure AVF Maturation Failure AVF maturation failure
AVF maturation failure two months postoperatively
Measured: up to 2 months
Secondary outcomes (4)
coagulation index
Change of coagulation index
Measured: up to 12 months
Platelet
Changes of platelet indexes
Measured: up to 12 months
Number of hospitalization
Number of hospitalization due to arteriovenous fistula thrombosis.
Measured: up to 12 months
Death
Death from any cause
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Jan 2019
- Primary completion1 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The enrolled patients will be randomly assigned to either the anticoagulant group or the control group. Patients in the anticoagulant group will receive a low-dose subcutaneous injection of low molecular weight heparin for the prevention of AVF thrombosis, starting 12-24 hours after the surgery. For patients weighing less than 80kg, enoxaparin sodium 4000IU will be administered once daily, while for those weighing over 80kg, enoxaparin sodium 4000IU will be administered every 12 hours. After discharge, these patients will be switched to oral low-dose warfarin for anticoagulation, with a daily dose of 1.25mg (half tablet) on dialysis days and 2.5mg/day on non-dialysis days. Patients with significantly excessive body weight may be considered for a daily dose of 2.5mg, with a total treatment duration of 4 weeks. Patients in the control group will not receive anticoagulants postoperatively, but both groups will routinely receive antiplatelet therapy.
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunfeng Xia, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Hua Gan, Dr., Study director, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164693
- Sponsor's protocol ID
- The First ChongQingMU
- Acronym
- EASOAT
- Status last verified
- Jun 2024
- First submitted
- 9 Nov 2019
- Last updated
- 24 Jun 2024
- 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 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula
- ClinicalTrials.gov ID
- NCT04164693
- Acronym / sponsor ID
- EASOAT / The First ChongQingMU
- Conditions
- Thrombosis
- Keywords
- manitenance hemodialysis, arteriovenous fistula, anticoagulant therapy, fistula function, bleeding risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 15 Nov 2019 (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.
Many guidelines at home and abroad advocate that arteriovenous fistula should be the first choice of permanent vascular access, but it is easy to form thrombus in a short time after arteriovenous fistula molding, resulting in internal fistula stenosis or occlusion. In this study, the investigators plan to screen the patients with arteriovenous fistula in the blood purification center of our hospital. Through the study design of random grouping and open label, the investigators will discuss the use of low molecular weight heparin or warfarin to prevent thrombosis in a short period of time after arteriovenous fistula operation. According to the research results, the investigators will understand efficacy and safety of short-term postoperative anticoagulant therapy to prevente thrombosis in arterovenous fistula.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The enrolled patients will be randomly assigned to either the anticoagulant group or the control group. Patients in the anticoagulant group will receive a low-dose subcutaneous injection of low molecular weight heparin for the prevention of AVF thrombosis, starting 12-24 hours after the surgery. For patients weighing less than 80kg, enoxaparin sodium 4000IU will be administered once daily, while for those weighing over 80kg, enoxaparin sodium 4000IU will be administered every 12 hours. After discharge, these patients will be switched to oral low-dose warfarin for anticoagulation, with a daily dose of 1.25mg (half tablet) on dialysis days and 2.5mg/day on non-dialysis days. Patients with significantly excessive body weight may be considered for a daily dose of 2.5mg, with a total treatment duration of 4 weeks. Patients in the control group will not receive anticoagulants postoperatively, but both groups will routinely receive antiplatelet therapy.
| Arm | Type | Receives |
|---|---|---|
| anticoagulant group | Experimental | Drug: Low molecular weight heparinPatients in the anticoagulant group received low-dose subcutaneous injection of low molecular weight heparin for prevention of AVF thrombosis, starting 12-24 hours after surgery. For patients weighing less than 80kg, enoxaparin sodium 4000IU was administered once daily, while for those weighing over 80kg, enoxaparin sodium 4000IU was administered every 12 hours. After discharge, these patients were switched to oral low-dose warfarin for anticoagulation, with a daily dose of 1.25mg (half tablet) on dialysis days, and 2.5mg/day on non-dialysis days. Patients with significantly excessive body weight may be considered for a daily dose of 2.5mg, with a total treatment duration of 4 weeks. |
| control group | Other | Other: non anticoagulant therapy groupPatients in the control group did not receive anticoagulants postoperatively, but both groups routinely received antiplatelet therapy. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- After AVF formation or balloon dilation surgery, there were no significant signs of oozing or bleeding at the surgical incision and operative site observed within 12-24 hours.
- The patient is willing to accept short-term anticoagulant therapy after the surgery, bear related risks, and sign an informed consent form.
- The patient is willing to cooperate with this study, undergo data collection related to the research, and relevant clinical examinations.
Key exclusion criteria (6 listed)
- Age >80 years;
- Concurrent hematologic diseases that can affect coagulation function;
- Concurrent comorbidities that can affect the patient's bleeding or coagulation functions, such as liver cirrhosis;
- Concurrent active bleeding disorders, such as active gastrointestinal ulcers or active lupus;
- History of major organ bleeding (e.g., intracranial or gastrointestinal) or surgery within the past six months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low molecular weight heparinAlso: warfarin sodium tabletspatients began to use low molecular weight heparin or warfarin sodium tablets. | Drug | anticoagulant group |
| non anticoagulant therapy groupno anticoagulant was used after operation. | Other | control group |
Primary outcome
Blood flow of arteriovenous fistula
Time frame: up to 12 months
Blood flow of arteriovenous fistula during hemodialysis from 6 months after operation
arteriovenous fistula dysfunction or occlusion
Time frame: up to 12 months
The proportion of arteriovenous fistula dysfunction or occlusion
Active bleeding events
Time frame: up to 12 months
such as,bleeding of surgical wound, intracranial, digestive tract and urinary tract, ecchymosis and ecchymosis of skin.
arteriovenous fistula dysfunction or occlusion
Time frame: up to 12 months
The time of arteriovenous fistula dysfunction or occlusion
AVF Maturation Failure AVF Maturation Failure AVF Maturation Failure AVF Maturation Failure AVF maturation failure
Time frame: up to 2 months
AVF maturation failure two months postoperatively
4 secondary outcomes
coagulation index
Time frame: up to 12 months
Platelet
Time frame: up to 12 months
Number of hospitalization
Time frame: up to 12 months
Death
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- 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. This study is not recruiting at the moment.
Hua Gan, Dr. study director
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low molecular weight heparin and non anticoagulant therapy group in people with Thrombosis, run by First Affiliated Hospital of Chongqing Medical University 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 24 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood flow of arteriovenous fistula (time frame: up to 12 months). The study lists 5 primary outcomes in all. 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 24 Jun 2024.