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

Pediatric Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081222
• Other study ID #: 2013-12-096
• Status: Completed
• Phase: N/A
• First received: March 5, 2014
• Last updated: November 10, 2015
• Start date: January 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Heart Defects, Congenital
• Heart Diseases
• Pediatric Patients
• Postoperative Hemorrhage
• Surgery for Congenital Heart Disease

Intervention

Procedure:
• surgery for congenital heart disease with cardiopulmonary bypass
surgery for congenital heart disease with cardiopulmonary bypass

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative blood loss	daily blood loss measured by chest tube drainage during seven days after surgery	during seven days after surgery	Yes
Secondary	postoperative transfusion requirements	postoperative transfusion requirements during seven days after surgery	during seven days after surgery	Yes