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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01889732

Enrollment

200

Registered

2013-06-28

Start date

2013-06-30

Completion date

2013-08-31

Last updated

2013-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Functional Disturbances Following Cardiac Surgery, Postoperative Hemorrhage, Coagulation Defect; Bleeding

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.

Interventions

DEVICEROTEM

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* cardiac surgical patients using Cardiopulmonary bypass

Exclusion criteria

* known coagulation disorder * Using deep hypothermic circulatory arrest * Using partial cardiopulmonary bypass

Design outcomes

Primary

Measure	Time frame	Description
early postoperative bleeding(chest tube drainage)	postoperative bleeding during 6hrs.	primary outcome is Chest tube drainage(blood volume) during 6hrs.

Countries

South Korea

Contacts

Primary Contactjonghwan lee, MD,PhD

jonghwan75.lee@samsung.com82-2-3410-1928

Backup Contacteunhee kim, MD

eunhee0720.kim@samsung.com82-2-3410-2470

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026