Surgery for Congenital Heart DiseaseNCT02081222
The Predictability of Intraoperative Rotational Thromboelastometry on Postoperative Bleeding and Transfusion Requirements
An observational study of Surgery for Congenital Heart Disease and Pediatric Patients, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Surgery for Congenital Heart Disease, Pediatric Patients
- What is being tested?
- surgery for congenital heart disease with cardiopulmonary bypass
- Type of treatment
- Surgery or procedure
- How many people
- 119 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric patients who underwent surgery for congential heart disease with cardiopulmonary bypass
Who may be able to join
- pediatric patients (< 10 years) who underwent surgery for congenital heart disease with cardiopulmonary bypass in 2013 at Samsung Medical Center
Who cannot join
- incomplete data about blood loss count or transfusion requirements during seven days after surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- surgery for congenital heart disease with cardiopulmonary bypass
- Keywords
- congenital heart disease, rotational thromboelastometry, blood loss, transfusion requirements
- Medical subject headings
- Heart Defects, Congenital, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery for congenital heart disease with cardiopulmonary bypassProcedure or surgery
surgery for congenital heart disease with cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| patients who underwent surgery for congenital heart disease | patients who underwent surgery for congenital heart disease in 2013 at Samsung Medical Center Receives: Procedure: surgery for congenital heart disease with cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative blood loss
daily blood loss measured by chest tube drainage during seven days after surgery
Measured: during seven days after surgery
Secondary outcomes (1)
postoperative transfusion requirements
postoperative transfusion requirements during seven days after surgery
Measured: during seven days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WonHo Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081222
- Sponsor's protocol ID
- 2013-12-096
- Status last verified
- Nov 2015
- First submitted
- 5 Mar 2014
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictability of Intraoperative Rotational Thromboelastometry on Postoperative Bleeding and Transfusion Requirements
- ClinicalTrials.gov ID
- NCT02081222
- Acronym / sponsor ID
- 2013-12-096
- Keywords
- congenital heart disease, rotational thromboelastometry, blood loss, transfusion requirements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who underwent surgery for congenital heart disease | – | Procedure: surgery for congenital heart disease with cardiopulmonary bypasspatients who underwent surgery for congenital heart disease in 2013 at Samsung Medical Center |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric patients who underwent surgery for congential heart disease with cardiopulmonary bypass
Key inclusion criteria (1 listed)
- pediatric patients (< 10 years) who underwent surgery for congenital heart disease with cardiopulmonary bypass in 2013 at Samsung Medical Center
Key exclusion criteria (1 listed)
- incomplete data about blood loss count or transfusion requirements during seven days after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgery for congenital heart disease with cardiopulmonary bypasssurgery for congenital heart disease with cardiopulmonary bypass | Procedure or surgery | patients who underwent surgery for congenital heart disease |
Primary outcome
postoperative blood loss
Time frame: during seven days after surgery
daily blood loss measured by chest tube drainage during seven days after surgery
1 secondary outcome
postoperative transfusion requirements
Time frame: during seven days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
Related trials for Surgery for Congenital Heart Disease
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
Active, not recruiting
Autus Valve Continued Access Study (CAS)
Congenital Heart Disease
Active, not recruiting
Autus Valve Pivotal Study
Congenital Heart Disease
Not yet recruitingObservational study
Neonatal Enhanced Recovery After Surgery (ERAS) Outcomes Study
Neonatal Patients Undergoing Major Non-cardiac Surgery, Congenital Anomaly
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery for Congenital Heart Disease and Pediatric Patients, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative blood loss (time frame: during seven days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.