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

Recruiting

• Conditions: Thromboelastography; Hemodialysis; Anticoagulation

• Registration Number: NCT06272708
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-29
• Status Verified: 2024-02
• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-22
• Last Update Posted: 2024-02-22
• Primary Completion: 2024-02-29
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
thromboelastography parameter R value	2 hours after hemodialysis began	Relationship between thromboelastography parameter R value and coagulation of hemodialysis circuit and dialyzer

Secondary Outcome Measures

Name	Time	Method
thromboelastography parameter MA	2 hours after hemodialysis began	Relationship between thromboelastography parameter MA value and coagulation of hemodialysis circuit and dialyzer
thromboelastography parameter K value	2 hours after hemodialysis began	Relationship between thromboelastography parameter K value and coagulation of hemodialysis circuit and dialyzer
thromboelastography parameter Angle	2 hours after hemodialysis began	Relationship between thromboelastography parameter Angle and coagulation of hemodialysis circuit and dialyzer

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China