NCT01889732

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

June 28, 2013

Status Verified

June 1, 2013

Enrollment Period

2 months

First QC Date

June 20, 2013

Last Update Submit

June 26, 2013

Conditions

Other Functional Disturbances Following Cardiac SurgeryPostoperative HemorrhageCoagulation Defect; Bleeding

Outcome Measures

Primary Outcomes (1)

  • early postoperative bleeding(chest tube drainage)

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

    postoperative bleeding during 6hrs.

Study Arms (1)

ROTEM

Device: ROTEM

Interventions

ROTEMDEVICE
ROTEM

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

elective cardiac surgical patient age 20-80years

You may qualify if:

  • cardiac surgical patients using Cardiopulmonary bypass

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Postoperative HemorrhageHemostatic DisordersHemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative ComplicationsVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • jonghwan lee, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • eunhee kim, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

jonghwan lee, MD,PhD

CONTACT

82-2-3410-1928jonghwan75.lee@samsung.com

eunhee kim, MD

CONTACT

82-2-3410-2470eunhee0720.kim@samsung.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2013

First Posted

June 28, 2013

Study Start

June 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

June 28, 2013

Record last verified: 2013-06

Locations

KR(1)