ThromboelastographyNCT06272708
Preliminary Exploration of Thromboelastography in the Monitoring of Anticoagulation in Maintenance Hemodialysis Patients
An observational study of Thromboelastography and Hemodialysis, run by RenJi Hospital at 1 site in China.
Trial summary
Objectives: To investigate the role of thromboelastography parameters (R, K, Angle, MA) in monitoring anticoagulation in maintenance hemodialysis (MHD) patients. Subjects: Two hundred stable MHD patients. Methods: An observational study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thromboelastography, Hemodialysis, Anticoagulation
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2024to 31 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stable patients undergoing maintanence hemodialysis
Who may be able to join
- male or female patients aged over 18 years
- stable patients undergoing maintenance hemodialysis treatment for at least 3 months
- signed informed consent form
Who cannot join
- concomitant with severe diseases such as active malignancy, severe liver diseases, systemic infection, etc.
- planned or ongoing pregnancy or lactation
- unsuitable for inclusion in this study after assessment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Yunyue Guo, 0086-021-68383312, guoyunyue@renji.com
About this study
Objectives: To investigate the role of thromboelastography parameters (R, K, Angle, MA) in monitoring anticoagulation in maintenance hemodialysis (MHD) patients.
Subjects: Two hundred stable MHD patients. Methods: An observational study. Primary outcome: Relationship between thromboelastography parameter R Value and coagulation of hemodialysis circuit and dialyzer.
Secondary outcome: Relationship between thromboelastography parameters (K Value, Angle and MA) and coagulation of hemodialysis circuit and dialyzer.
- Conditions
- Thromboelastography, Hemodialysis, Anticoagulation
What is being measured
The primary outcome is the main question the study is designed to answer.
thromboelastography parameter R value
Relationship between thromboelastography parameter R value and coagulation of hemodialysis circuit and dialyzer
Measured: 2 hours after hemodialysis began
Secondary outcomes (3)
thromboelastography parameter K value
Relationship between thromboelastography parameter K value and coagulation of hemodialysis circuit and dialyzer
Measured: 2 hours after hemodialysis began
thromboelastography parameter Angle
Relationship between thromboelastography parameter Angle and coagulation of hemodialysis circuit and dialyzer
Measured: 2 hours after hemodialysis began
thromboelastography parameter MA
Relationship between thromboelastography parameter MA value and coagulation of hemodialysis circuit and dialyzer
Measured: 2 hours after hemodialysis began
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start29 Jan 2024
- Primary completion29 Feb 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboelastographyStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renhua Lu, RenJi Hospital
- Investigators
- Yiwei Shen, MD, Principal investigator, RenJi HospitalRenhua Lu, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272708
- Sponsor's protocol ID
- IIT-2023-0356
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Exploration of Thromboelastography in the Monitoring of Anticoagulation in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06272708
- Acronym / sponsor ID
- IIT-2023-0356
- Conditions
- Thromboelastography, Hemodialysis, Anticoagulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 22 Feb 2024 (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.
Objectives: To investigate the role of thromboelastography parameters (R, K, Angle, MA) in monitoring anticoagulation in maintenance hemodialysis (MHD) patients.
Subjects: Two hundred stable MHD patients. Methods: An observational study. Primary outcome: Relationship between thromboelastography parameter R Value and coagulation of hemodialysis circuit and dialyzer.
Secondary outcome: Relationship between thromboelastography parameters (K Value, Angle and MA) and coagulation of hemodialysis circuit and dialyzer.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stable patients undergoing maintanence hemodialysis
Key inclusion criteria (3 listed)
- male or female patients aged over 18 years
- stable patients undergoing maintenance hemodialysis treatment for at least 3 months
- signed informed consent form
Key exclusion criteria (3 listed)
- concomitant with severe diseases such as active malignancy, severe liver diseases, systemic infection, etc.
- planned or ongoing pregnancy or lactation
- unsuitable for inclusion in this study after assessment
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
thromboelastography parameter R value
Time frame: 2 hours after hemodialysis began
Relationship between thromboelastography parameter R value and coagulation of hemodialysis circuit and dialyzer
3 secondary outcomes
thromboelastography parameter K value
Time frame: 2 hours after hemodialysis began
thromboelastography parameter Angle
Time frame: 2 hours after hemodialysis began
thromboelastography parameter MA
Time frame: 2 hours after hemodialysis began
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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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.
Yiwei Shen, MD principal investigator
RenJi Hospital
Renhua Lu, MD principal investigator
RenJi 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 Thromboelastography and Hemodialysis, run by RenJi Hospital 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 3 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 22 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yiwei Shen, MD (0086-18121099413, shenyiwei08@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thromboelastography parameter R value (time frame: 2 hours after hemodialysis began). 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 22 Feb 2024.