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NCT01889732 Clinical Trial

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

Postoperative Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01889732
Other study ID # SMC 2013-05-060
Secondary ID
Status Recruiting
Phase N/A
First received June 20, 2013
Last updated June 26, 2013
Start date June 2013
Est. completion date August 2013

Study information
Verified date June 2013
Source Samsung Medical Center
Contact jonghwan lee, MD,PhD
Phone 82-2-3410-1928
Email jonghwan75.lee@samsung.com
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- cardiac surgical patients using Cardiopulmonary bypass

Exclusion Criteria:

- known coagulation disorder

- Using deep hypothermic circulatory arrest

- Using partial cardiopulmonary bypass

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Device:
• ROTEM

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary early postoperative bleeding(chest tube drainage) primary outcome is Chest tube drainage(blood volume) during 6hrs. postoperative bleeding during 6hrs. No
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