Ultrafiltration on Coagulation Performance in Cardiac Surgery

Cardiac Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05252559
• Other study ID #: 2019-05-008
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 1, 2022
• Est. primary completion date: May 1, 2022
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Valve Disease
• Heart Valve Diseases

Intervention

Procedure:
• ultrafiltration
In cardiac surgery patients, ultrafiltration is usually applied to reduce free water and concentrate all blood components before weaning from cardiopulmonary bypass

Diagnostic Test:
• maximal clot firmness in EXTEM assay of ROTEM test
before and after applying ultrafiltration, arterial blood sample underwent EXTEM and FIBTEM assays of rotational thromboelastometry

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximal clot firmness (MCF) of EXTEM assay	change of MCF-EXTEM assay	30 minute after the completion of ultrafiltration
Secondary	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
Secondary	maximal clot firmness (MCF) of EXTEM assay to be improved by 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
Secondary	maximal clot firmness (MCF) of EXTEM assay not to be improved by 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