Clinical Trials Directory

Trials / Completed

CompletedNCT05252559

Ultrafiltration on Coagulation Performance in Cardiac Surgery

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

Status
Completed
Phase
Study type
Observational
Enrollment
75 (actual)
Sponsor
Konkuk University Medical Center · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREultrafiltrationIn cardiac surgery patients, ultrafiltration is usually applied to reduce free water and concentrate all blood components before weaning from cardiopulmonary bypass
DIAGNOSTIC_TESTmaximal clot firmness in EXTEM assay of ROTEM testbefore and after applying ultrafiltration, arterial blood sample underwent EXTEM and FIBTEM assays of rotational thromboelastometry

Timeline

Start date
2021-08-01
Primary completion
2022-05-01
Completion
2022-06-01
First posted
2022-02-23
Last updated
2022-06-10

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT05252559. Inclusion in this directory is not an endorsement.