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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01889732
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 2
• Patients Per Site Per Month: 99.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Other Functional Disturbances Following Cardiac Surgery; Postoperative Hemorrhage; Coagulation Defect; Bleeding	Device: ROTEM

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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
• Study Start Date: Jun 1, 2013
• Anticipated Primary Completion Date: Aug 1, 2013
• Anticipated Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
ROTEM	Device: ROTEM

Outcome Measures

Primary Outcome Measures

1. early postoperative bleeding(chest tube drainage) [postoperative bleeding during 6hrs.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• cardiac surgical patients using Cardiopulmonary bypass

Exclusion Criteria:

• known coagulation disorder

• Using deep hypothermic circulatory arrest

• Using partial cardiopulmonary bypass

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

• Samsung Medical Center

Investigators

• Principal Investigator: jonghwan lee, MD, PhD, Samsung Medical Center
• Principal Investigator: eunhee kim, MD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT01889732
• Other Study ID Numbers: SMC 2013-05-060
• First Posted: Jun 28, 2013
• Last Update Posted: Jun 28, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Postoperative Hemorrhage

Study Results

No Results Posted as of Jun 28, 2013