Clinical trial NCT05252559: Ultrafiltration on Coagulation Performance in Cardiac Surgery
Official title: Effect of Modified Ultrafiltration on Whole Blood Coagulation in Cardiac Surgery With Cardiopulmonary Bypass: Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Valve Disease
Keywords: ultrafiltration
cardiac valve disease
viscoelastic test
cardiopulmonary bypass
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 75
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent elective cardiac valve surgery with moderate hypothermic CPB and ultrafiltration

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.

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

Primary outcomes:
measure: maximal clot firmness (MCF) of EXTEM assay
timeFrame: 30 minute after the completion of ultrafiltration
Secondary outcomes:
measure: cut-off value of MCF-EXTEM to be improved by ultrafiltration
timeFrame: 30 minute after the completion of ultrafiltration
measure: maximal clot firmness (MCF) of EXTEM assay to be improved by ultrafiltration
timeFrame: 30 minute after the completion of ultrafiltration
measure: maximal clot firmness (MCF) of EXTEM assay not to be improved by ultrafiltration
timeFrame: 30 minute after the completion of ultrafiltration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
References: