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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02081222
Enrollment
119
Registered
2014-03-07
Start date
2014-01-31
Completion date
2015-11-30
Last updated
2015-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Patients, Surgery for Congenital Heart Disease

Keywords

congenital heart disease, rotational thromboelastometry, blood loss, transfusion requirements

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.

Interventions

PROCEDUREsurgery for congenital heart disease with cardiopulmonary bypass

surgery for congenital heart disease with cardiopulmonary bypass

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative blood lossduring seven days after surgerydaily blood loss measured by chest tube drainage during seven days after surgery

Secondary

MeasureTime frameDescription
postoperative transfusion requirementsduring seven days after surgerypostoperative transfusion requirements during seven days after surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026