Other Functional Disturbances Following Cardiac SurgeryNCT01889732
A Gray Zone Approach of Rotational Thromboelastometry for Predicting Postoperative Bleeding in Cardiac Surgical Patients
An observational study of Other Functional Disturbances Following Cardiac Surgery and Postoperative Hemorrhage, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Rotational thromboelastometry (ROTEM) is reliable point of care management of coagulation disorder undergoing surgery. Recently, there are some reports about prediction of perioperative bleeding using ROTEM. But, the effectiveness of ROTEM for predict bleeding and improve outcomes is still debate. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Other Functional Disturbances Following Cardiac Surgery, Postoperative Hemorrhage, Coagulation Defect; Bleeding
- What is being tested?
- ROTEM
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Aug 2013
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: elective cardiac surgical patient age 20-80years
Who may be able to join
- cardiac surgical patients using Cardiopulmonary bypass
Who cannot join
- known coagulation disorder
- Using deep hypothermic circulatory arrest
- Using partial cardiopulmonary bypass
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Jonghwan lee, MD,PhD, 82-2-3410-1928, jonghwan75.lee@samsung.com
Eunhee Kim, MD, 82-2-3410-2470, eunhee0720.kim@samsung.com
About this study
Official title: The Effectiveness Evaluation of Rotational Thromboelastometry(ROTEM) for Predicting Postoperative Bleeding in Cardiac Surgical Patients Using a Gray Zone Approach : A Preliminary Retrospective Study
Rotational thromboelastometry (ROTEM) is reliable point of care management of coagulation disorder undergoing surgery. Recently, there are some reports about prediction of perioperative bleeding using ROTEM. But, the effectiveness of ROTEM for predict bleeding and improve outcomes is still debate. In this retrospective study, the investigators will compare immediate postoperative bleeding with ROTEM parameters using a Gray zone approach, and access the reliability of ROTEM for prediction of bleeding after cardiac surgery.
- Conditions
- Other Functional Disturbances Following Cardiac Surgery, Postoperative Hemorrhage, Coagulation Defect; Bleeding
- Being tested
- ROTEM
- Medical subject headings
- Postoperative Hemorrhage, Hemostatic Disorders, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTEMDevice
| Study group | Role | What they receive |
|---|---|---|
| ROTEM | Not described Receives: Device: ROTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
early postoperative bleeding(chest tube drainage)
primary outcome is Chest tube drainage(blood volume) during 6hrs.
Measured: postoperative bleeding during 6hrs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Functional Disturbances Following Cardiac SurgeryStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jonghwan lee, MD, PhD, Principal investigator, Samsung Medical Centereunhee kim, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889732
- Sponsor's protocol ID
- SMC 2013-05-060
- Status last verified
- Jun 2013
- First submitted
- 20 Jun 2013
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness Evaluation of Rotational Thromboelastometry(ROTEM) for Predicting Postoperative Bleeding in Cardiac Surgical Patients Using a Gray Zone Approach : A Preliminary Retrospective Study
- ClinicalTrials.gov ID
- NCT01889732
- Acronym / sponsor ID
- SMC 2013-05-060
- Conditions
- Other Functional Disturbances Following Cardiac Surgery, Postoperative Hemorrhage, Coagulation Defect; Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 28 Jun 2013 (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.
Rotational thromboelastometry (ROTEM) is reliable point of care management of coagulation disorder undergoing surgery. Recently, there are some reports about prediction of perioperative bleeding using ROTEM. But, the effectiveness of ROTEM for predict bleeding and improve outcomes is still debate. In this retrospective study, the investigators will compare immediate postoperative bleeding with ROTEM parameters using a Gray zone approach, and access the reliability of ROTEM for prediction of bleeding after cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ROTEM | – | Device: ROTEM |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- elective cardiac surgical patient age 20-80years
Key inclusion criteria (1 listed)
- cardiac surgical patients using Cardiopulmonary bypass
Key exclusion criteria (3 listed)
- known coagulation disorder
- Using deep hypothermic circulatory arrest
- Using partial cardiopulmonary bypass
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 |
|---|---|---|
| ROTEM | Device | ROTEM |
Primary outcome
early postoperative bleeding(chest tube drainage)
Time frame: postoperative bleeding during 6hrs.
primary outcome is Chest tube drainage(blood volume) during 6hrs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
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.
jonghwan lee, MD, PhD principal investigator
Samsung Medical Center
eunhee kim, MD principal investigator
Samsung Medical Center
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 Other Functional Disturbances Following Cardiac Surgery and Postoperative Hemorrhage, 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 3 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: status not confirmed, as of the sponsor's last update on 28 Jun 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jonghwan lee, MD,PhD (82-2-3410-1928, jonghwan75.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early postoperative bleeding(chest tube drainage) (time frame: postoperative bleeding during 6hrs.). 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 28 Jun 2013; AzTrials last refreshed its copy on 31 Oct 2026.