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Ultrafiltration on Coagulation Function in Cardiac Surgery

Primary Purpose

Cardiac Valve Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultrafiltration
Sponsored by
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Valve Disease focused on measuring coagulation, ultrafiltration, cardiac surgery

Eligibility Criteria

19 Months - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Konkuk University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrafiltration

Arm Description

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

Outcomes

Primary Outcome Measures

Change of Maximal clot formation (MCF) in rotational thromboelastometry, EXTEM assay
change of MCF in EXTEM assay before and after applying ultrafiltration

Secondary Outcome Measures

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

Full Information

First Posted
July 21, 2019
Last Updated
May 6, 2023
Sponsor
Konkuk University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04031144
Brief Title
Ultrafiltration on Coagulation Function in Cardiac Surgery
Official Title
Effect of Ultrafiltration Before Weaning From Cardiopulmonary Bypass on Post-bypass Coagulation Function in Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Valve Disease
Keywords
coagulation, ultrafiltration, cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with reduced clot strength before applying ultrafiltration (patients with MCF in ROTEM-EXTEM less than the cut-off value which will be determined by preliminary analyses, n=30). ROC analysis of the preliminary data was performed and the cut-off values 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 by applying ultrafiltration was 25, with a 2-sided significance level of 0.05 and a statistical power of 0.80. Considering 10% of the possible loss, 28 patients will be recruited for the present study. Patients who scheduled for elective cardiac surgery with cardiopulmonary bypass are recruited first, and the data of patients with MCF <50.5 mm will be included to the final analysis.
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrafiltration
Arm Type
Experimental
Arm Description
Ultrafiltration is applied at the end of cardiopulmonary bypass. Maximal clot formation (MCF) of ROTEM-EXTEM tracing is reduced before applying the ultrafiltration.
Intervention Type
Procedure
Intervention Name(s)
Ultrafiltration
Intervention Description
At the end of CPB procedure, free water is partly removed by ultrafiltration to increase relative mass of red blood cell and plasma components.
Primary Outcome Measure Information:
Title
Change of Maximal clot formation (MCF) in rotational thromboelastometry, EXTEM assay
Description
change of MCF in EXTEM assay before and after applying ultrafiltration
Time Frame
5 min-before and 5 min-after applying ultrafiltration
Secondary Outcome Measure Information:
Title
Change of Clotting time (CT) in rotational thromboelastometry, EXTEM assay
Description
change of CT in EXTEM assay before and after applying ultrafiltration
Time Frame
5 min-before and 5 min-after applying ultrafiltration
Title
Change of Maximal clot formation at 5 min (A5) in rotational thromboelastometry, FIBTEM assay
Description
change of A5 in FIBTEM assay before and after applying ultrafiltration
Time Frame
5 min-before and 5 min-after applying ultrafiltration
Title
Change of Percent of lysis (lysis%) in rotational thromboelastometry, EXTEM assay
Description
change of lysis% before and after applying ultrafiltration
Time Frame
5 min-before and 5 min-after applying ultrafiltration
Title
Hematocrit (Hct) change
Description
change of Hct before and after applying ultrafiltration
Time Frame
5 min-before and 5 min-after applying ultrafiltration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Months
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seong-Ho Lee
Phone
82-2-2030-6542
Email
20190508@kuh.ac.kr
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong Ho Lee
Phone
82-2-2030-6542
Email
20190508@kuh.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Ultrafiltration on Coagulation Function in Cardiac Surgery

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