The Effectiveness Evaluation of Rotational Thromboelastometry(ROTEM) for Predicting Postoperative Bleeding in Cardiac Surgical Patients Using a Gray Zone Approach : A Preliminary Retrospective Study

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

Sponsors

Lead sponsor: Samsung Medical Center

Source Samsung Medical Center
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.

Overall Status Unknown status
Start Date June 2013
Completion Date August 2013
Primary Completion Date August 2013
Study Type Observational
Primary Outcome
Measure Time Frame
early postoperative bleeding(chest tube drainage) postoperative bleeding during 6hrs.
Enrollment 200
Condition
Intervention

Intervention type: Device

Intervention name: ROTEM

Arm group label: ROTEM

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- cardiac surgical patients using Cardiopulmonary bypass

Exclusion Criteria:

- known coagulation disorder

- Using deep hypothermic circulatory arrest

- Using partial cardiopulmonary bypass

Gender: All

Minimum age: 20 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
jonghwan lee, MD,PhD jonghwan lee, MD,PhD jonghwan lee, MD,PhD
82-2-3410-1928 82-2-3410-1928 82-2-3410-1928
[email protected] [email protected] [email protected]
Overall Contact

Last name: jonghwan lee, MD,PhD

Phone: 82-2-3410-1928

Email: [email protected]

Location
facility status contact contact_backup investigator
Samsung Medical Center Recruiting Jonghwan lee, MD,PhD 82-2-3410-1928 [email protected] Jonghwan Lee, MD,PhD Principal Investigator Eunhee Kim, MD Principal Investigator
Location Countries

Korea, Republic of

Verification Date

June 2013

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: ROTEM

Study Design Info

Observational model: Cohort

Time perspective: Retrospective

Source: ClinicalTrials.gov