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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02081222
• Collaborator: (none)
• Enrollment: 119
• Location: 1
• Duration (Months): 22
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery for Congenital Heart Disease; Pediatric Patients	Procedure: surgery for congenital heart disease with cardiopulmonary bypass

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 119 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Predictability of Intraoperative Rotational Thromboelastometry on Postoperative Bleeding and Transfusion Requirements
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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; surgery for congenital heart disease with cardiopulmonary bypass

Outcome Measures

Primary Outcome Measures

1. postoperative blood loss [during seven days after surgery]

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

Secondary Outcome Measures

1. postoperative transfusion requirements [during seven days after surgery]

   postoperative transfusion requirements during seven days after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 10 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: WonHo Kim, Assistant Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT02081222
• Other Study ID Numbers: 2013-12-096
• First Posted: Mar 7, 2014
• Last Update Posted: Nov 13, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by WonHo Kim, Assistant Professor, Samsung Medical Center: congenital heart disease; rotational thromboelastometry; blood loss; transfusion requirements
• Additional relevant MeSH terms: Heart Diseases; Heart Defects, Congenital; Postoperative Hemorrhage

Study Results

No Results Posted as of Nov 13, 2015