NCT06272708

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

February 15, 2024

Last Update Submit

February 15, 2024

Conditions

ThromboelastographyHemodialysisAnticoagulation

Outcome Measures

Primary Outcomes (1)

  • thromboelastography parameter R value

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

    2 hours after hemodialysis began

Secondary Outcomes (3)

  • thromboelastography parameter K value

    2 hours after hemodialysis began

  • thromboelastography parameter Angle

    2 hours after hemodialysis began

  • thromboelastography parameter MA

    2 hours after hemodialysis began

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

stable patients undergoing maintanence hemodialysis

You may qualify if:

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

You may not qualify if:

  • concomitant with severe diseases such as active malignancy, severe liver diseases, systemic infection, etc.
  • planned or ongoing pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Study Officials

  • Yiwei Shen, MD

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

  • Renhua Lu, MD

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiwei Shen, MD

CONTACT

0086-18121099413shenyiwei08@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 22, 2024

Study Start

January 29, 2024

Primary Completion

February 29, 2024

Study Completion

May 31, 2024

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations

CN(1)