Platelet ActivationNCT05165797
Platelet Activation Affecting the Rate of Vascular Access Patency
An observational study of Platelet Activation and Hemodialysis Fistula Thrombosis, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
In the case of cardiovascular diseases such as coronary artery disease, cerebrovascular disease, and peripheral arterial disease, there are many studies that the use of antiplatelet agents is very helpful in improving the vascular patency rate, but there are not many studies on the use of antiplatelet agents in the… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Platelet Activation, Hemodialysis Fistula Thrombosis
- What is being tested?
- platelet activation factors
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2021to 1 Jul 2022
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing dialysis access route formation for the purpose of hemodialysis at this institution
Who may be able to join
- Patients 19 years of age or older who are undergoing hemodialysis during renal replacement therapy
- Patients undergoing arteriovenous fistula formation and hemodialysis to the affected area
- Patients who have the ability and willingness to consent to participate in the clinical study, have signed the consent form in accordance with the appropriate procedures, and can visit and participate in the clinical study as planned
Who cannot join
- Patients who failed to start hemodialysis with an arteriovenous fistula within 3 months
- Patients who have had stent implantation or surgery during the study period due to cardiovascular disease
- Patients with severe hepatic impairment
- Patients with coagulopathy and liver disease associated with clinically significant bleeding risk
- Patients with clinically significant bleeding or bleeding risk
- Patients who underwent artificial heart valve replacement requiring anticoagulant administration
- Patients with pulmonary embolism who are hemodynamically unstable or require thrombolysis or pulmonary embolization.
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea university anam hospital
Seoul, Non US/Canada, 02841
Jun Gyo Gwon, MD. PhD., +82 10 3270 2137, doctorgjg@gmail.com
About this study
Official title: Platelet Activation Affecting the Rate of Vascular Access Patency; Single Center, Prospective Observational Study
In the case of cardiovascular diseases such as coronary artery disease, cerebrovascular disease, and peripheral arterial disease, there are many studies that the use of antiplatelet agents is very helpful in improving the vascular patency rate, but there are not many studies on the use of antiplatelet agents in the dialysis approach. The basis for use is insufficient. There is a lack of research on whether maintaining a state in which platelet activation is suppressed is helpful in improving dialysis access patency. Therefore, we conducted this study to determine whether the degree of platelet activation affects the patency of vascular access.
- Being tested
- platelet activation factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet activation factorsBiological
platelet activation factors of subject blood
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular access primary patency
Time from vascular access creation until hemodialysis related procedure
Measured: 1 month
Secondary outcomes (1)
Vascular access secondary patency
Time from vascular access creation until hemodialysis failure
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet ActivationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gwon, Jun Gyo, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165797
- Sponsor's protocol ID
- KoreaUAnamH
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) cannot be shared with other researchers as it is the patient's medical information.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Activation Affecting the Rate of Vascular Access Patency; Single Center, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05165797
- Acronym / sponsor ID
- KoreaUAnamH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 21 Dec 2021 (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.
In the case of cardiovascular diseases such as coronary artery disease, cerebrovascular disease, and peripheral arterial disease, there are many studies that the use of antiplatelet agents is very helpful in improving the vascular patency rate, but there are not many studies on the use of antiplatelet agents in the dialysis approach. The basis for use is insufficient. There is a lack of research on whether maintaining a state in which platelet activation is suppressed is helpful in improving dialysis access patency. Therefore, we conducted this study to determine whether the degree of platelet activation affects the patency of vascular access.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing dialysis access route formation for the purpose of hemodialysis at this institution
Key inclusion criteria (3 listed)
- Patients 19 years of age or older who are undergoing hemodialysis during renal replacement therapy
- Patients undergoing arteriovenous fistula formation and hemodialysis to the affected area
- Patients who have the ability and willingness to consent to participate in the clinical study, have signed the consent form in accordance with the appropriate procedures, and can visit and participate in the clinical study as planned
Key exclusion criteria (8 listed)
- Patients who failed to start hemodialysis with an arteriovenous fistula within 3 months
- Patients who have had stent implantation or surgery during the study period due to cardiovascular disease
- Patients with severe hepatic impairment
- Patients with coagulopathy and liver disease associated with clinically significant bleeding risk
- Patients with clinically significant bleeding or bleeding risk
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 |
|---|---|---|
| platelet activation factorsplatelet activation factors of subject blood | Biological | – |
Primary outcome
Vascular access primary patency
Time frame: 1 month
Time from vascular access creation until hemodialysis related procedure
1 secondary outcome
Vascular access secondary patency
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: No. Individual participant data (IPD) cannot be shared with other researchers as it is the patient's medical information.
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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.
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 Platelet Activation and Hemodialysis Fistula Thrombosis, run by Korea University Anam Hospital at 1 site in South Korea.
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 8 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: status not confirmed, as of the sponsor's last update on 21 Dec 2021. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular access primary patency (time frame: 1 month). 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 21 Dec 2021.