Ultrafiltration on Coagulation Performance in Cardiac Sur... | NCT05252559

Studies
Ultrafiltration on Coagulation Performance in Cardiac Surgery

NCT05252559

Sponsor

Konkuk University Medical Center

Status

Completed

Last Update Posted

Jun 10, 2022Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Cardiac Valve Disease

Interventions

ultrafiltration
maximal clot firmness in EXTEM assay of ROTEM test

Countries

South Korea

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

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2021Actual

Primary Completion Date

May 1, 2022Actual

Completion Date

Jun 1, 2022Actual

First Submitted Date

Jan 25, 2022

First Submission Date that Met QC Criteria

Feb 13, 2022

First Posted Date

Feb 23, 2022Actual

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

Jun 8, 2022

Last Update Posted Date

Jun 10, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical CenterPrincipal Investigator

Lead Sponsor

Konkuk University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

In cardiac surgery patients with CPB-induced dilutional coagulopathy, ultrafiltration (UF) was applied to reduce free water and concentrate all blood components before the weaning from CPB. The impact of UF on the clot strength is determined by analyzing the changes of maximal clot formation in EXTEM assay (MCF-EXTEM) in the ROTEM test in patients who underwent elective cardiac valve surgery in KUMC.

Detailed Description

In cardiac surgery patients, ultrafiltration (UF) was applied to reduce free water and concentrate all blood components during cardiopulmonary bypass (CPB). Concentrating plasma substrate of UF would be beneficial in attenuating CPB-induced dilutional coagulopathy. This study was to investigate whether MUF affected viscoelastic profiles during CPB for cardiac surgery.

Patients who underwent elective cardiac surgery and MUF at the end of CPB during January 2019-December 2021 are recruited. Using the patients' electronic medical records, the values of maximum clot firmness of EXTEM assay (MCF-EXTEM) of rotational thromboelastometry (ROTEM) test before and after applying MUF are retrospectively analyzed.

As the primary measure, we determine the changes of MCF-EXTEM after applying MUF. With an assumption that MUF increased MCF-EXTEM, the receiver operating characteristic (ROC) analysis is applied to MCF-EXTEM change. The area under the ROC curve is determined and the cut-off value is estimated with specificity and sensitivity in Youden's J statistics. The change of MCF-EXTEM in patients who show MCF-EXTEM less than the cut-off value is analyzed. The changes of hematocrit (Hct) before and after applying MUF is also determined.

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

75Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrafiltration	Procedure	In cardiac surgery patients, ultrafiltration is usually applied to reduce free water and concentrate all blood components before weaning from cardiopulmonary bypass
maximal clot firmness in EXTEM assay of ROTEM test	Diagnostic Test	before and after applying ultrafiltration, arterial blood sample underwent EXTEM and FIBTEM assays of rotational thromboelastometry

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
maximal clot firmness (MCF) of EXTEM assay	change of MCF-EXTEM assay	30 minute after the completion of ultrafiltration

Secondary Outcomes

Measure	Description	Time Frame
cut-off value of MCF-EXTEM to be improved by ultrafiltration	To estimate the cut-off value of MCF-EXTEM which can be increased by applying ultrafiltration	30 minute after the completion of ultrafiltration
maximal clot firmness (MCF) of EXTEM assay to be improved by ultrafiltration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients underwent cardiac surgery during Jan 2019-Dec 2021
Patients underwent moderate hypothermic CPB
Patients underwent ultrafiltration during CPB
Patients underwent ROTEM tests (EXTEM assays and FIBTEM assay) before and after applying ultrafiltration

Exclusion Criteria:

Patients underwent packed RBC transfusion > 3 units during CPB
patients underwent ultrafiltration but the removed free water was < 250 ml
Patients underwent deep hypothermia

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients underwent elective cardiac valve surgery with moderate hypothermic CPB and ultrafiltration

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Konkuk University Medical Center		Seoul		05030	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006349	Heart Valve Diseases

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014462	Ultrafiltration

Ancestor Terms

ID	Term
D005112	Extracorporeal Circulation
D013514	Surgical Procedures, Operative
D005374	Filtration
D002623	Chemistry Techniques, Analytical

Browse Leaves

Not provided

Browse Branches

Not provided