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Clinical Trials/NCT06272708
NCT06272708RecruitingNot Applicable

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

RenJi Hospital1 site in 1 country200 target enrollmentStarted: January 29, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
200
Locations
1
Primary Endpoint
thromboelastography parameter R value
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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. 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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

thromboelastography parameter R value

Time Frame: 2 hours after hemodialysis began

Relationship between thromboelastography parameter R value and coagulation of hemodialysis circuit and dialyzer

Secondary Outcomes

  • thromboelastography parameter MA(2 hours after hemodialysis began)
  • thromboelastography parameter K value(2 hours after hemodialysis began)
  • thromboelastography parameter Angle(2 hours after hemodialysis began)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Renhua Lu

Chief Physician

RenJi Hospital

Study Sites (1)

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