CClinicalTrials.gg
Status unknownNCT01889732Updated Jun 28, 2013

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

An observational study in Other Functional Disturbances Following Cardiac Surgery, Postoperative Hemorrhage and Coagulation Defect; Bleeding, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-06-28.

Sponsored by Samsung Medical Center · Observational

The sponsor has not verified this record recently (last verified Jun 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Other Functional Disturbances Following Cardiac Surgery
  • Postoperative Hemorrhage
  • Coagulation Defect; Bleeding
03

In context

Hemostatic Disorders

503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 229 observational studies indexed under Hemostatic Disorders.

Browse Hemostatic Disorders studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

elective cardiac surgical patient age 20-80years

Inclusion criteria

  • cardiac surgical patients using Cardiopulmonary bypass

Exclusion criteria

Exclusion Criteria:

  • known coagulation disorder
  • Using deep hypothermic circulatory arrest
  • Using partial cardiopulmonary bypass
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • ROTEM

    Device: ROTEM

Interventions

  • DeviceROTEM
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What researchers measure

Primary outcomes

  1. early postoperative bleeding(chest tube drainage)

    primary outcome is Chest tube drainage(blood volume) during 6hrs.

    Time frame: postoperative bleeding during 6hrs.

07

Study locations

1 of 1 sites recruiting
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01889732
Lead sponsor
Samsung Medical Center
Responsible party
Sponsor
First posted
Jun 28, 2013
Start date
Jun 2013
Primary completion
Aug 2013 (estimated)
Completion
Aug 2013 (estimated)
Last update
Jun 28, 2013

Study contacts

jonghwan lee, MD,PhD
Contact
jonghwan75.lee@samsung.com
82-2-3410-1928
eunhee kim, MD
Contact
eunhee0720.kim@samsung.com
82-2-3410-2470
jonghwan lee, MD, PhD
principal investigator · Samsung Medical Center
eunhee kim, MD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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