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

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

Sponsors

Lead sponsor: Samsung Medical Center

Source 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.

Overall Status Completed
Start Date January 2014
Completion Date November 2015
Primary Completion Date November 2015
Study Type Observational
Primary Outcome
Measure Time Frame
postoperative blood loss during seven days after surgery
Secondary Outcome
Measure Time Frame
postoperative transfusion requirements during seven days after surgery
Enrollment 119
Condition
Intervention

Intervention type: Procedure

Intervention name: surgery for congenital heart disease with cardiopulmonary bypass

Description: surgery for congenital heart disease with cardiopulmonary bypass

Arm group label: patients who underwent surgery for congenital heart disease

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: 10 Years

Healthy volunteers: No

Location
facility Samsung Medical Center
Location Countries

Korea, Republic of

Verification Date

November 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Samsung Medical Center

Investigator full name: WonHo Kim

Investigator title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: patients who underwent surgery for congenital heart disease

Description: patients who underwent surgery for congenital heart disease in 2013 at Samsung Medical Center

Study Design Info

Observational model: Cohort

Time perspective: Retrospective

Source: ClinicalTrials.gov