Ultrafiltration on Coagulation Performance in Cardiac Surgery

June 8, 2022 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center

Effect of Modified Ultrafiltration on Whole Blood Coagulation in Cardiac Surgery With Cardiopulmonary Bypass: Retrospective Analysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cut-off value of MCF-EXTEM to be improved by ultrafiltration
Time Frame: 30 minute after the completion of 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
Time Frame: 30 minute after the completion of ultrafiltration
change of MCF-EXTEM by applying ultrafiltration in patients with reduced MCF-EXTEM before applying ultrafiltration (MCF-EXTEM < the estimated cut-off value)
30 minute after the completion of ultrafiltration
maximal clot firmness (MCF) of EXTEM assay not to be improved by ultrafiltration
Time Frame: 30 minute after the completion of ultrafiltration
change of MCF-EXTEM by applying ultrafiltration in patients with reduced MCF-EXTEM before applying ultrafiltration (MCF-EXTEM > the estimated cut-off value)
30 minute after the completion of ultrafiltration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

February 13, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Actual)

June 10, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-05-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Valve Disease

Clinical Trials on ultrafiltration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe