MedDataX Logo

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

NCT ID: NCT02081222

Last Updated: 2015-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Gray Zone Approach of Rotational Thromboelastometry for Predicting Postoperative Bleeding in Cardiac Surgical Patients

NCT01889732

Other Functional Disturbances Following Cardiac Surgery Postoperative Hemorrhage Coagulation Defect; Bleeding
UNKNOWN

ROTEM Versus aPTT/PT in Pediatric Surgery

NCT03699813

Coagulation Defect; Bleeding
COMPLETED

Perioperative Coagulation Management in Cardiac Surgery.

NCT00772239

Cardiac Surgery Bleeding
TERMINATED NA

Predictions of Bleeding During Liver Transplantation With Thromboelastometry

NCT02356068

Hemorrhage
COMPLETED

Blood Products Transfusion in Cardiac Surgery After the Implementation of a Coagulation Monitoring System at Patient Bedside: Thromboelastometry Versus Standard Transfusion Protocol

NCT01919840

Hemostatic Disorders
TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery for Congenital Heart Disease Pediatric Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients who underwent surgery for congenital heart disease

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

surgery for congenital heart disease with cardiopulmonary bypass

Intervention Type PROCEDURE

surgery for congenital heart disease with cardiopulmonary bypass

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

surgery for congenital heart disease with cardiopulmonary bypass

surgery for congenital heart disease with cardiopulmonary bypass

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

WonHo Kim

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-12-096

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

TEG Use in Children Undergoing Procedures With High Anticipated Blood Loss
NCT05379530 NOT_YET_RECRUITING NA
Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant
NCT02239991 UNKNOWN NA
Heparin's Influence on ROTEM® Analysis
NCT01455454 COMPLETED
ROTEM in Patients With Placenta Previa
NCT04213755 COMPLETED
Goal-orientated Therapy of Perioperative Disturbance in Hemostasis in Cardiac Surgery
NCT00516126 COMPLETED
Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery
NCT03064152 TERMINATED NA
Blood Transfusion and Postoperative Outcome Before and After Implementing a Coagulation Management Algorithm
NCT03482128 COMPLETED
Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients
NCT02461251 COMPLETED NA
ROTEM-guided Transfusion Protocol in Attempt to Reduce Blood Transfusions in Major Oncological Surgery
NCT03993977 WITHDRAWN NA
A Prospective Evaluation of Thromboelastography for Identifying Coagulopathy in Severely Injured Patients
NCT01228058 COMPLETED
Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery
NCT05806346 RECRUITING NA
Conventional Versus Point-of-care Based Coagulation Management
NCT00997841 COMPLETED PHASE4
Rotational Thromboelastometry Guided Blood Component Use in Children With Cirrhosis Undergoing Invasive Procedures: A Randomized Controlled Trial
NCT04460222 COMPLETED NA
Thromboelastometry-identified Haemostatic Changes in Isolated Traumatic Brain Injury
NCT03616808 COMPLETED NA
Tranexamic Acid in Pediatric Scoliosis Surgery
NCT06091891 UNKNOWN NA
Thromboelastography (TEG®) and Platelet Function in Patients on Anti-platelet Agents
NCT00901160 TERMINATED
A Comparative Evaluation of TEG Versus ROTEM for Coagulopathy Correction
NCT05333510 COMPLETED
Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery
NCT05957822 RECRUITING PHASE4
Biological and Clinical Relevance of Quantra Viscoelastic Hemostatic Assay in Hemorrhagic Cardiac Surgery
NCT07105904 RECRUITING
Comparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis
NCT03703323 TERMINATED NA
Optimal Prophylactic Method of Venous Thromboembolism (VTE)
NCT01448746 UNKNOWN PHASE3
Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood Component Use in Patients With Cirrhosis of Liver With Non-variceal Bleeding.
NCT06153082 RECRUITING NA
Bleeding Prediction in Patients Following Cardiac Surgery Using Whole Blood Aggregometry and Thromboelastometry
NCT01281397 TERMINATED
Heparin Solution and INTEM/HEPTEM Analysis
NCT01522846 COMPLETED
Viscoelastic Tests (VET) Versus Conventional Coagulation Tests (CCT) for Management of Trauma-Induced Coagulopathy
NCT06820879 NOT_YET_RECRUITING NA