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Completed

NCT Number: NCT02191449

The Influence of Preoperative Warfarin Medication on Thromboelastography and Blood 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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Konkuk University Medical Center

Seoul, 143-729, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Rotational Thromboelastography : Clotting time (CT)

    Time frame: 30min after anesthetic induction and 15 mins after CPB weaning status

Secondary outcomes

  1. Rotational Thromboelastography : clot formation time (CFT)

    Time frame: 30min after anesthetic induction and 15 mins after CPB weaning status

Other outcomes

  1. Rotational Thromboelastography : maximum clot firmness (MCF)

    Time frame: 30min after anesthetic induction and 15 mins after CPB weaning status

  2. Rotational Thromboelastography : maximum lysis (ML) level Rotational Thromboelastography : maximum lysis (ML) level

    Time frame: 30min after anesthetic induction and 15 mins after CPB weaning status

  3. amount of Blood transfusion

    Time frame: intraoperative (during operation) and postoperative (during admission, an expected average of 5 weeks)

  4. Coagulation values : preprothrombin time (PT)

    Time frame: preoperative (maximum 5days before operation) and postoperative (30min after ICU admission)

  5. Coagulation values : activated partial thromboplastin time (aPTT)

    Time frame: preoperative (maximum 5days before operation) and postoperative (30min after ICU admission)

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Influence of Warfarin on Thromboelastography and Transfusion

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 16, 2014
Registry last updated
Feb 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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