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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 20, 2013
First Posted Date June 28, 2013
Last Update Posted Date June 28, 2013
Study Start Date June 2013
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2013)
early postoperative bleeding(chest tube drainage) [ Time Frame: postoperative bleeding during 6hrs. ]
primary outcome is Chest tube drainage(blood volume) during 6hrs.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Gray Zone Approach of Rotational Thromboelastometry for Predicting Postoperative Bleeding in Cardiac Surgical Patients
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population elective cardiac surgical patient age 20-80years
Condition
  • Other Functional Disturbances Following Cardiac Surgery
  • Postoperative Hemorrhage
  • Coagulation Defect; Bleeding
Intervention Device: ROTEM
Study Groups/Cohorts ROTEM
Intervention: Device: ROTEM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 26, 2013)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2013
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • cardiac surgical patients using Cardiopulmonary bypass

Exclusion Criteria:

  • known coagulation disorder
  • Using deep hypothermic circulatory arrest
  • Using partial cardiopulmonary bypass
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01889732
Other Study ID Numbers SMC 2013-05-060
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Samsung Medical Center
Study Sponsor Samsung Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: jonghwan lee, MD, PhD Samsung Medical Center
Principal Investigator: eunhee kim, MD Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date June 2013