Preliminary Exploration of Thromboelastography in the Mon... | NCT06272708

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

NCT06272708

Sponsor

RenJi Hospital

Status

Unknown status

Last Update Posted

Feb 22, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Thromboelastography
Hemodialysis
Anticoagulation

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 29, 2024Actual

Primary Completion Date

Feb 29, 2024Estimated

Completion Date

May 31, 2024Estimated

First Submitted Date

Feb 15, 2024

First Submission Date that Met QC Criteria

Feb 15, 2024

First Posted Date

Feb 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2024

Last Update Posted Date

Feb 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

stable patients undergoing maintanence hemodialysis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yiwei Shen, MD	Contact	0086-18121099413		shenyiwei08@126.com

Overall Officials

Name	Affiliation	Role
Yiwei Shen, MD	RenJi Hospital	Principal Investigator
Renhua Lu, MD	RenJi Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Recruiting	Shanghai	Shanghai Municipality	200127	China