Ultrafiltration on Coagulation Function in Cardiac Surgery

NCT04031144 | Completed DMC

• 1 other identifier: KUMC 2019-05-008
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effect of modified ultrafiltration, which is usually employed for reducing free water at the end of cardiopulmonary bypass (CPB), on coagulation profile in patients undergoing cardiac surgery

Conditions

Cardiac Valve Disease

Keywords

coagulation; ultrafiltration; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Change of Maximal clot formation (MCF) in rotational thromboelastometry, EXTEM assay

  change of MCF in EXTEM assay before and after applying ultrafiltration

  5 min-before and 5 min-after applying ultrafiltration

Secondary Outcomes (4)

• Change of Clotting time (CT) in rotational thromboelastometry, EXTEM assay

  5 min-before and 5 min-after applying ultrafiltration

• Change of Maximal clot formation at 5 min (A5) in rotational thromboelastometry, FIBTEM assay

  5 min-before and 5 min-after applying ultrafiltration

• Change of Percent of lysis (lysis%) in rotational thromboelastometry, EXTEM assay

  5 min-before and 5 min-after applying ultrafiltration

• Hematocrit (Hct) change

  5 min-before and 5 min-after applying ultrafiltration

Study Arms (1)

Ultrafiltration

EXPERIMENTAL

Ultrafiltration is applied at the end of cardiopulmonary bypass. Maximal clot formation (MCF) of ROTEM-EXTEM tracing is reduced before applying the ultrafiltration.

Procedure: Ultrafiltration

Interventions

Ultrafiltration PROCEDURE

At the end of CPB procedure, free water is partly removed by ultrafiltration to increase relative mass of red blood cell and plasma components.

Ultrafiltration

Eligibility Criteria

• Age: 19 Months - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB)
• maximal clot formation (MCF) in ROTEM-EXTEM is reduced (\< 50.5 mm before applying ultrafiltration)

You may not qualify if:

• transfusion of packed RBC\> 3 units during CPB
• total ultrafiltration volume \< 250 ml
• hyperfibrinolysis (lysis% \> 10%) before applying ultrafiltration

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, Seoul, 05030, South Korea

Location

MeSH Terms

Conditions

Heart Valve Diseases; Thrombosis

Interventions

Ultrafiltration

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

Extracorporeal Circulation; Surgical Procedures, Operative; Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Physical Phenomena; Chemical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: Patients with reduced clot strength before applying ultrafiltration (patients with MCF in ROTEM-EXTEM less than the cut-off value, determined by preliminary analyses, n=30). ROC analysis of the preliminary data was performed, and the cut-off value was 50.5 mm. The sample size of the present study is determined by using these data. The minimum sample size to detect the observed difference after applying ultrafiltration was 26. Considering 50% possible loss, 39 patients will be recruited for the primary analysis. Patients scheduled for elective cardiac surgery with cardiopulmonary bypass are recruited first, and the data from patients with MCF \<50.5 mm will be included in the final analysis.

Study Record Dates

• First Submitted: July 21, 2019
• First Posted: July 24, 2019
• Study Start: January 30, 2020
• Primary Completion: September 30, 2023
• Study Completion: October 30, 2023
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

KR (1)