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A Gray Zone Approach of Rotational Thromboelastometry for Predicting Postoperative Bleeding in Cardiac Surgical Patients

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ClinicalTrials.gov Identifier: NCT01889732
Recruitment Status : Unknown
Verified June 2013 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Study Description
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Brief Summary:
Rotational thromboelastometry (ROTEM) is reliable point of care management of coagulation disorder undergoing surgery. Recently, there are some reports about prediction of perioperative bleeding using ROTEM. But, the effectiveness of ROTEM for predict bleeding and improve outcomes is still debate. In this retrospective study, the investigators will compare immediate postoperative bleeding with ROTEM parameters using a Gray zone approach, and access the reliability of ROTEM for prediction of bleeding after cardiac surgery.

Condition or disease Intervention/treatment
Other Functional Disturbances Following Cardiac Surgery Postoperative Hemorrhage Coagulation Defect; Bleeding Device: ROTEM

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Effectiveness Evaluation of Rotational Thromboelastometry(ROTEM) for Predicting Postoperative Bleeding in Cardiac Surgical Patients Using a Gray Zone Approach : A Preliminary Retrospective Study
Study Start Date : June 2013
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Groups and Cohorts
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Group/Cohort Intervention/treatment
ROTEM Device: ROTEM


Outcome Measures
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Primary Outcome Measures :
  1. early postoperative bleeding(chest tube drainage) [ Time Frame: postoperative bleeding during 6hrs. ]
    primary outcome is Chest tube drainage(blood volume) during 6hrs.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
elective cardiac surgical patient age 20-80years
Criteria

Inclusion Criteria:

  • cardiac surgical patients using Cardiopulmonary bypass

Exclusion Criteria:

  • known coagulation disorder
  • Using deep hypothermic circulatory arrest
  • Using partial cardiopulmonary bypass
Contacts and Locations
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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): NCT01889732


Contacts
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Contact: jonghwan lee, MD,PhD 82-2-3410-1928 jonghwan75.lee@samsung.com
Contact: eunhee kim, MD 82-2-3410-2470 eunhee0720.kim@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Jonghwan lee, MD,PhD    82-2-3410-1928    jonghwan75.lee@samsung.com   
Contact: Eunhee Kim, MD    82-2-3410-2470    eunhee0720.kim@samsung.com   
Principal Investigator: Jonghwan Lee, MD,PhD         
Principal Investigator: Eunhee Kim, MD         
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: jonghwan lee, MD, PhD Samsung Medical Center
Principal Investigator: eunhee kim, MD Samsung Medical Center
More Information
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01889732    
Other Study ID Numbers: SMC 2013-05-060
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
 Postoperative Complications
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders