Ultrafiltration on Coagulation Function in Cardiac Surgery

May 6, 2023 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center

Effect of Ultrafiltration Before Weaning From Cardiopulmonary Bypass on Post-bypass Coagulation Function in Cardiac Surgery

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB)
  • maximal clot formation (MCF) in ROTEM-EXTEM is reduced

Exclusion Criteria:

  • MCF > 50.5 mm before applying ultrafiltration
  • transfusion of packed RBC> 3 units during CPB
  • total ultrafiltration volume < 250 ml
  • hyperfibrinolysis (lysis% > 10%) before applying ultrafiltration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrafiltration
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
At the end of CPB procedure, free water is partly removed by ultrafiltration to increase relative mass of red blood cell and plasma components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Maximal clot formation (MCF) in rotational thromboelastometry, EXTEM assay
Time Frame: 5 min-before and 5 min-after applying ultrafiltration
change of MCF in EXTEM assay before and after applying ultrafiltration
5 min-before and 5 min-after applying ultrafiltration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Clotting time (CT) in rotational thromboelastometry, EXTEM assay
Time Frame: 5 min-before and 5 min-after applying ultrafiltration
change of CT in EXTEM assay before and after applying ultrafiltration
5 min-before and 5 min-after applying ultrafiltration
Change of Maximal clot formation at 5 min (A5) in rotational thromboelastometry, FIBTEM assay
Time Frame: 5 min-before and 5 min-after applying ultrafiltration
change of A5 in FIBTEM assay before and after applying ultrafiltration
5 min-before and 5 min-after applying ultrafiltration
Change of Percent of lysis (lysis%) in rotational thromboelastometry, EXTEM assay
Time Frame: 5 min-before and 5 min-after applying ultrafiltration
change of lysis% before and after applying ultrafiltration
5 min-before and 5 min-after applying ultrafiltration
Hematocrit (Hct) change
Time Frame: 5 min-before and 5 min-after applying ultrafiltration
change of Hct before and after applying ultrafiltration
5 min-before and 5 min-after applying ultrafiltration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2020

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

October 30, 2023

Study Registration Dates

First Submitted

July 21, 2019

First Submitted That Met QC Criteria

July 21, 2019

First Posted (Actual)

July 24, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 6, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUMC 2019-05-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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