Ultrafiltration on Coagulation Performance in Cardiac Surgery
Effect of Modified Ultrafiltration on Whole Blood Coagulation in Cardiac Surgery With Cardiopulmonary Bypass: Retrospective Analysis
1 other identifier
observational
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
January 25, 2022
CompletedFirst Posted
Study publicly available on registry
February 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJune 10, 2022
June 1, 2022
9 months
January 25, 2022
June 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
maximal clot firmness (MCF) of EXTEM assay
change of MCF-EXTEM assay
30 minute after the completion of ultrafiltration
Secondary Outcomes (3)
cut-off value of MCF-EXTEM to be improved by ultrafiltration
30 minute after the completion of ultrafiltration
maximal clot firmness (MCF) of EXTEM assay to be improved by ultrafiltration
30 minute after the completion of ultrafiltration
maximal clot firmness (MCF) of EXTEM assay not to be improved by ultrafiltration
30 minute after the completion of ultrafiltration
Interventions
In cardiac surgery patients, ultrafiltration is usually applied to reduce free water and concentrate all blood components before weaning from cardiopulmonary bypass
before and after applying ultrafiltration, arterial blood sample underwent EXTEM and FIBTEM assays of rotational thromboelastometry
Eligibility Criteria
Patients underwent elective cardiac valve surgery with moderate hypothermic CPB and ultrafiltration
You may qualify if:
- 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
You may not qualify if:
- Patients underwent packed RBC transfusion \> 3 units during CPB
- patients underwent ultrafiltration but the removed free water was \< 250 ml
- Patients underwent deep hypothermia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Konkuk University Medical Center
Seoul, 05030, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Anesthesiology
Study Record Dates
First Submitted
January 25, 2022
First Posted
February 23, 2022
Study Start
August 1, 2021
Primary Completion
May 1, 2022
Study Completion
June 1, 2022
Last Updated
June 10, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share