The Predictability of Intraoperative Rotational Thromboelastometry on Postoperative Bleeding and Transfusion Requirements

Completed

• Conditions: Surgery for Congenital Heart Disease; Pediatric Patients
• Interventions: Procedure: surgery for congenital heart disease with cardiopulmonary bypass

• Registration Number: NCT02081222
• Lead Sponsor: Samsung Medical Center

Brief Summary

Viscoelastic hemostatic assay has been reported to be superior to predict perioperative bleeding in cardiac surgical patients compared with conventional blood coagulation test. However, the role of rotational thromboelastometry (ROTEM) in predicting perioperative bleeding and transfusion requirements in pediatric patients who undergoing surgery for congenital heart disease. Therefore, the investigators attempt to evaluate the predictability of intraoperative rotational thromboelastometry for perioperative bleeding and transfusion requirements in pediatric cardiac surgical patients by comparing with conventional coagulation test. The investigators also attempt to evaluate the correlation between ROTEM parameters, platelet count, and results of conventional coagulation test results.

Detailed Description

Viscoelastic hemostatic assay has been reported to be superior to predict perioperative bleeding in cardiac surgical patients compared with conventional blood coagulation test. However, the role of rotational thromboelastometry (ROTEM) in predicting perioperative bleeding and transfusion requirements in pediatric patients who undergoing surgery for congenital heart disease. Therefore, the investigators attempt to evaluate the predictability of intraoperative rotational thromboelastometry for perioperative bleeding and transfusion requirements in pediatric cardiac surgical patients by comparing with conventional coagulation test. The investigators also attempt to evaluate the correlation between ROTEM parameters, platelet count, and results of conventional coagulation test results.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-07
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-10
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• pediatric patients (< 10 years) who underwent surgery for congenital heart disease with cardiopulmonary bypass in 2013 at Samsung Medical Center

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Exclusion Criteria

• incomplete data about blood loss count or transfusion requirements during seven days after surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients who underwent surgery for congenital heart disease	surgery for congenital heart disease with cardiopulmonary bypass	patients who underwent surgery for congenital heart disease in 2013 at Samsung Medical Center

Primary Outcome Measures

Name	Time	Method
postoperative blood loss	during seven days after surgery	daily blood loss measured by chest tube drainage during seven days after surgery

Secondary Outcome Measures

Name	Time	Method
postoperative transfusion requirements	during seven days after surgery	postoperative transfusion requirements during seven days after surgery

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of