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

NCT ID: NCT01889732

Last Updated: 2013-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ROTEM

ROTEM

Intervention Type DEVICE

Interventions

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ROTEM

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* cardiac surgical patients using Cardiopulmonary bypass

Exclusion Criteria

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

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jonghwan lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

eunhee kim, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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jonghwan lee, MD,PhD

Role: CONTACT

Phone: 82-2-3410-1928

Email: [email protected]

eunhee kim, MD

Role: CONTACT

Phone: 82-2-3410-2470

Email: [email protected]

Facility Contacts

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Jonghwan lee, MD,PhD

Role: primary

Eunhee Kim, MD

Role: backup

Other Identifiers

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SMC 2013-05-060

Identifier Type: -

Identifier Source: org_study_id