Preliminary Exploration of Thromboelastography in the Monitoring of Anticoagulation in Maintenance Hemodialysis Patients

February 15, 2024 updated by: Renhua Lu, RenJi Hospital

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

stable patients undergoing maintanence hemodialysis

Description

Inclusion Criteria:

  1. male or female patients aged over 18 years
  2. stable patients undergoing maintenance hemodialysis treatment for at least 3 months
  3. signed informed consent form

Exclusion Criteria:

  1. concomitant with severe diseases such as active malignancy, severe liver diseases, systemic infection, etc.
  2. planned or ongoing pregnancy or lactation
  3. unsuitable for inclusion in this study after assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
thromboelastography parameter R value
Time Frame: 2 hours after hemodialysis began
Relationship between thromboelastography parameter R value and coagulation of hemodialysis circuit and dialyzer
2 hours after hemodialysis began

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
thromboelastography parameter K value
Time Frame: 2 hours after hemodialysis began
Relationship between thromboelastography parameter K value and coagulation of hemodialysis circuit and dialyzer
2 hours after hemodialysis began
thromboelastography parameter Angle
Time Frame: 2 hours after hemodialysis began
Relationship between thromboelastography parameter Angle and coagulation of hemodialysis circuit and dialyzer
2 hours after hemodialysis began
thromboelastography parameter MA
Time Frame: 2 hours after hemodialysis began
Relationship between thromboelastography parameter MA value and coagulation of hemodialysis circuit and dialyzer
2 hours after hemodialysis began

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Yiwei Shen, MD, RenJi Hospital
  • Principal Investigator: Renhua Lu, MD, RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2024

Primary Completion (Estimated)

February 29, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Estimated)

February 22, 2024

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IIT-2023-0356

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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