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The Influence of Preoperative Warfarin Medication on Thromboelastography and Blood Transfusion

Influence of Warfarin on Thromboelastography and Transfusion

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02191449
Enrollment
107
Registered
2014-07-16
Start date
2014-06-30
Completion date
2015-02-28
Last updated
2015-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief 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. 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: 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. Patients were categorized by two groups. 1. W group: patients on atrial fibrillation who have taken warfarin for p.o medication. 2. C group: patients on atrial fibrillation who have not taken warfarin for p.o medication. Using blood sample, authors examined as follows: 1. Preoperative (maximum 5days before operation) and postoperative (30min after ICU admission) coagulation values with haematologic values: PT/aPTT, INR, Hb, Hct, platelet levels. 2. 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) 3. Intraoperative (during operation) and postoperative (during admission, an expected average of 5 weeks) total transfusion amount: RBC, FFP, PC, cryoprecipitate. 4. Post operative 24 hr bleeding amount in the chest tube drain bottle. 5. 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.

Interventions

None listed

Sponsors

Konkuk University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
Rotational Thromboelastography : Clotting time (CT)30min after anesthetic induction and 15 mins after CPB weaning status

Secondary

MeasureTime frame
Rotational Thromboelastography : clot formation time (CFT)30min after anesthetic induction and 15 mins after CPB weaning status

Other

MeasureTime frame
amount of Blood transfusionintraoperative (during operation) and postoperative (during admission, an expected average of 5 weeks)
Rotational Thromboelastography : maximum clot firmness (MCF)30min after anesthetic induction and 15 mins after CPB weaning status
Coagulation values : activated partial thromboplastin time (aPTT)preoperative (maximum 5days before operation) and postoperative (30min after ICU admission)
Coagulation values : preprothrombin time (PT)preoperative (maximum 5days before operation) and postoperative (30min after ICU admission)
Rotational Thromboelastography : maximum lysis (ML) level Rotational Thromboelastography : maximum lysis (ML) level30min after anesthetic induction and 15 mins after CPB weaning status

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026