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

NCT02081222 | Completed

• 1 other identifier: 2013-12-096
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery for Congenital Heart Disease; Pediatric Patients

Keywords

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

Outcome Measures

Primary Outcomes (1)

• postoperative blood loss

  daily blood loss measured by chest tube drainage during seven days after surgery

  during seven days after surgery

Secondary Outcomes (1)

• postoperative transfusion requirements

  during seven days after surgery

Study Arms (1)

patients who underwent surgery for congenital heart disease

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

Procedure: surgery for congenital heart disease with cardiopulmonary bypass

Interventions

surgery for congenital heart disease with cardiopulmonary bypass PROCEDURE

surgery for congenital heart disease with cardiopulmonary bypass

patients who underwent surgery for congenital heart disease

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

pediatric patients who underwent surgery for congential heart disease with cardiopulmonary bypass

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Hemorrhage

Interventions

Surgical Procedures, Operative; Cardiopulmonary Bypass

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Extracorporeal Circulation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 7, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 13, 2015

Record last verified: 2015-11

Locations

KR (1)