NCT02191449

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 25, 2015

Status Verified

February 1, 2015

Enrollment Period

8 months

First QC Date

June 29, 2014

Last Update Submit

February 23, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rotational Thromboelastography : Clotting time (CT)

    30min after anesthetic induction and 15 mins after CPB weaning status

Secondary Outcomes (1)

  • Rotational Thromboelastography : clot formation time (CFT)

    30min after anesthetic induction and 15 mins after CPB weaning status

Other Outcomes (5)

  • Rotational Thromboelastography : maximum clot firmness (MCF)

    30min after anesthetic induction and 15 mins after CPB weaning status

  • Rotational Thromboelastography : maximum lysis (ML) level Rotational Thromboelastography : maximum lysis (ML) level

    30min after anesthetic induction and 15 mins after CPB weaning status

  • amount of Blood transfusion

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

  • +2 more other outcomes

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing cardiac surgery with Maze-operation

You may qualify if:

  • \. 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

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Seong-Hyop Kim, M.D,Ph.D

    Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2014

First Posted

July 16, 2014

Study Start

June 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 25, 2015

Record last verified: 2015-02

Locations