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

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06272708
• Other study ID #: IIT-2023-0356
• Status: Recruiting
• Start date: January 29, 2024
• Est. completion date: May 31, 2024

Study information

• Verified date: February 2024
• Source: RenJi Hospital
• Contact: Yiwei Shen, MD
• Phone: 0086-18121099413
• Email: shenyiwei08[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 31, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulation
• Hemodialysis

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thromboelastography parameter R value	Relationship between thromboelastography parameter R value and coagulation of hemodialysis circuit and dialyzer	2 hours after hemodialysis began
Secondary	thromboelastography parameter K value	Relationship between thromboelastography parameter K value and coagulation of hemodialysis circuit and dialyzer	2 hours after hemodialysis began
Secondary	thromboelastography parameter Angle	Relationship between thromboelastography parameter Angle and coagulation of hemodialysis circuit and dialyzer	2 hours after hemodialysis began
Secondary	thromboelastography parameter MA	Relationship between thromboelastography parameter MA value and coagulation of hemodialysis circuit and dialyzer	2 hours after hemodialysis began