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Trial record 74 of 226 for:    warfarin AND International

The Influence of Preoperative Warfarin Medication on Thromboelastography and Blood Transfusion

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ClinicalTrials.gov Identifier: NCT02191449
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : February 25, 2015
Sponsor:
Information provided by (Responsible Party):
Konkuk University Medical Center

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.

Condition or disease
Atrial Fibrillation

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.


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Study Type : Observational
Actual Enrollment : 107 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Influence of Warfarin on Thromboelastography and Transfusion
Study Start Date : June 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015





Primary Outcome Measures :
  1. Rotational Thromboelastography : Clotting time (CT) [ Time Frame: 30min after anesthetic induction and 15 mins after CPB weaning status ]

Secondary Outcome Measures :
  1. Rotational Thromboelastography : clot formation time (CFT) [ Time Frame: 30min after anesthetic induction and 15 mins after CPB weaning status ]

Other Outcome Measures:
  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) ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing cardiac surgery with Maze-operation
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191449


Locations
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Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Sponsors and Collaborators
Konkuk University Medical Center
Investigators
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Principal Investigator: Seong-Hyop Kim, M.D,Ph.D Konkuk University Medical Center

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Responsible Party: Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT02191449     History of Changes
Other Study ID Numbers: KUH1160068
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: February 25, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants