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Completed

NCT Number: NCT05252559

Ultrafiltration on Coagulation Performance in Cardiac Surgery

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.

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Key information

Conditions

Cardiac Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Konkuk University Medical Center

Seoul, 05030, South Korea

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. maximal clot firmness (MCF) of EXTEM assay

    Time frame: 30 minute after the completion of ultrafiltration

    change of MCF-EXTEM assay

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2022
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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