Atrial FibrillationNCT02191449
The Influence of Preoperative Warfarin Medication on Thromboelastography and Blood Transfusion
An observational study of Atrial Fibrillation, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
Warfarin therapy is usually monitored using the international normalized ratio (INR), and prolonged INR means coagulation impairment that can leads elevating transfusion requirement after operation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 107 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery with Maze-operation
Who may be able to join
- 1. Patients who have atrial fibrillation undergoing cardiac surgery with Maze-operation.
- W group : Patients who have had warfarin therapy before operation due to treat Atrial fibrillation
- C group : Patients who have not had warfarin therapy before operation
Who cannot join
- 1. Patients who have taken medicine related to coagulation (such as antiplatelets like aspirin and clopidogrel) except warfarin or bridged heparin.
- 2. Patients whose laboratory values could not be confirmed by medical records review.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Warfarin on Thromboelastography and Transfusion
Warfarin therapy is usually monitored using the international normalized ratio (INR), and prolonged INR means coagulation impairment that can leads elevating transfusion requirement after operation. This study was designed to assess the relationships with warfarin and TEG values related to transfusion amount, to set up blood transfusion strategy in patients on atrial fibrillation undergoing cardiac surgery.
Read the detailed description
This study was a retrospective evaluation of patients who have received cardiac surgery with Maze-operation from March 2008 to November 2013.
Patients who have atrial fibrillation undergoing cardiac surgery with Maze-operation were included.
The following exclusion criteria are applied:
- Patients who have taken medicine related to coagulation (such as antiplatelets like aspirin and clopidogrel) except warfarin or bridged heparin
- Patients whose laboratory values could not be confirmed by medical records review.
Patients were categorized by two groups.
- W group: patients on atrial fibrillation who have taken warfarin for p.o medication.
- C group: patients on atrial fibrillation who have not taken warfarin for p.o medication.
Using blood sample, authors examined as follows:
- Preoperative (maximum 5days before operation) and postoperative (30min after ICU admission) coagulation values with haematologic values: PT/aPTT, INR, Hb, Hct, platelet levels.
- ROTEM values at 30min after anaesthetic induction and 30min after ICU admission: Clotting time (CT), clot formation time (CFT), maximum clot firmness (MCF), maximum lysis (ML)
- Intraoperative (during operation) and postoperative (during admission, an expected average of 5 weeks) total transfusion amount: RBC, FFP, PC, cryoprecipitate.
- Post operative 24 hr bleeding amount in the chest tube drain bottle.
- The duration (maximum 2 weeks) of warfarin discontinuation. (in W group)
Statistical analysis was performed using unpaired t-test and chi-square test to compare patients demographic data and other parameters. To determine the relationship of INR and ROTEM parameters with bleeding amount and transfusion amount, multiple linear regression model that accounted for all confounder variables was used. For each factor in the multiple regression model, variables with a p value of less than 0.10 were kept in the final model. The data was analyzed using the program Statistical Package for the Social Sciences ver. 18.0 (SPSS Inc, Chicago, USA). A value of p < 0.05 was considered statistically significant.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotational Thromboelastography : Clotting time (CT)
Measured: 30min after anesthetic induction and 15 mins after CPB weaning status
Secondary outcomes (1)
Rotational Thromboelastography : clot formation time (CFT)
Measured: 30min after anesthetic induction and 15 mins after CPB weaning status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seong-Hyop Kim, M.D,Ph.D, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191449
- Sponsor's protocol ID
- KUH1160068
- Status last verified
- Feb 2015
- First submitted
- 29 Jun 2014
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Warfarin on Thromboelastography and Transfusion
- ClinicalTrials.gov ID
- NCT02191449
- Acronym / sponsor ID
- KUH1160068
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Warfarin therapy is usually monitored using the international normalized ratio (INR), and prolonged INR means coagulation impairment that can leads elevating transfusion requirement after operation. This study was designed to assess the relationships with warfarin and TEG values related to transfusion amount, to set up blood transfusion strategy in patients on atrial fibrillation undergoing cardiac surgery.
Detailed description
This study was a retrospective evaluation of patients who have received cardiac surgery with Maze-operation from March 2008 to November 2013.
Patients who have atrial fibrillation undergoing cardiac surgery with Maze-operation were included.
The following exclusion criteria are applied:
- Patients who have taken medicine related to coagulation (such as antiplatelets like aspirin and clopidogrel) except warfarin or bridged heparin
- Patients whose laboratory values could not be confirmed by medical records review.
Patients were categorized by two groups.
- W group: patients on atrial fibrillation who have taken warfarin for p.o medication.
- C group: patients on atrial fibrillation who have not taken warfarin for p.o medication.
Using blood sample, authors examined as follows:
- Preoperative (maximum 5days before operation) and postoperative (30min after ICU admission) coagulation values with haematologic values: PT/aPTT, INR, Hb, Hct, platelet levels.
- ROTEM values at 30min after anaesthetic induction and 30min after ICU admission: Clotting time (CT), clot formation time (CFT), maximum clot firmness (MCF), maximum lysis (ML)
- Intraoperative (during operation) and postoperative (during admission, an expected average of 5 weeks) total transfusion amount: RBC, FFP, PC, cryoprecipitate.
- Post operative 24 hr bleeding amount in the chest tube drain bottle.
- The duration (maximum 2 weeks) of warfarin discontinuation. (in W group)
Statistical analysis was performed using unpaired t-test and chi-square test to compare patients demographic data and other parameters. To determine the relationship of INR and ROTEM parameters with bleeding amount and transfusion amount, multiple linear regression model that accounted for all confounder variables was used. For each factor in the multiple regression model, variables with a p value of less than 0.10 were kept in the final model. The data was analyzed using the program Statistical Package for the Social Sciences ver. 18.0 (SPSS Inc, Chicago, USA). A value of p < 0.05 was considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery with Maze-operation
Key inclusion criteria (3 listed)
- 1. Patients who have atrial fibrillation undergoing cardiac surgery with Maze-operation.
- W group : Patients who have had warfarin therapy before operation due to treat Atrial fibrillation
- C group : Patients who have not had warfarin therapy before operation
Key exclusion criteria (2 listed)
- 1. Patients who have taken medicine related to coagulation (such as antiplatelets like aspirin and clopidogrel) except warfarin or bridged heparin.
- 2. Patients whose laboratory values could not be confirmed by medical records review.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rotational Thromboelastography : Clotting time (CT)
Time frame: 30min after anesthetic induction and 15 mins after CPB weaning status
1 secondary outcome
Rotational Thromboelastography : clot formation time (CFT)
Time frame: 30min after anesthetic induction and 15 mins after CPB weaning status
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2015.
Related trials for Atrial Fibrillation
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seong-Hyop Kim, M.D,Ph.D principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotational Thromboelastography : Clotting time (CT) (time frame: 30min after anesthetic induction and 15 mins after CPB weaning status). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2015.