Brain TumorNCT01522846
Heparin Solution and INTEM/HEPTEM Analysis
An observational study of Brain Tumor and Spinal Stenosis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Heparinized solution has been used for maintenance of arterial catheter during perioperative period. Although the infused dose of heparin is very low, the investigators examine whether the heparin effect is remained or not in blood using rotational thromboelastometry (ROTEM) analysis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Brain Tumor, Spinal Stenosis, Cerebral Artery Anuerysm
- What is being tested?
- Heparin
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring continuous invasive arterial pressure monitoring during operation for anesthetic management.
Who may be able to join
- Patients requiring continuous invasive arterial pressure monitoring during operation for anesthetic management.
Who cannot join
- heparin hypersensitivity
- hematologic disease
- anticoagulant medication
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seonnam, Gyounggi, 463-707
About this study
Official title: Influence by Heparinized Flush Solution of the Radial Artery Catheter: INTEM and HEPTEM Analysis.
Heparinized solution has been used for maintenance of arterial catheter during perioperative period. Although the infused dose of heparin is very low, the investigators examine whether the heparin effect is remained or not in blood using rotational thromboelastometry (ROTEM) analysis.
- Conditions
- Brain Tumor, Spinal Stenosis, Cerebral Artery Anuerysm
- Being tested
- Heparin
- Medical subject headings
- Brain Neoplasms, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
Heparinized flush solution contained heparin concentration of 2 unit/ml and continuous flow of the flush solution was 5 ml/h at 300 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Heparin | Not described Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
INTEM test
INTEM is not an abbriviation. INTEM is one of the ROTEM test and it is an coagulation test name (such as prothrombin time test) using patient's whole blood. We put the blood sample of patinet into the machine, so the result comes out automatically. It will be checked twice at pre- and postopertive 30 minute and it'll be analyzed and compared.
Measured: at 30 min before operation and 30 min after operation
HEPTEM test
HEPTEM is not an abbriviation. HEPTEM is one of the ROTEM test and it is an coagulation test name (such as prothrombin time test) using patient's whole blood. We put the blood sample of patinet into the machine, so the result comes out automatically. It will be checked twice at pre- and postopertive 30 minute and it'll be analyzed and compared.
Measured: at 30 min before operation and 30 min after operation
Secondary outcomes (1)
Total infused units of heparin
Measured: periond from starting operation to finishing operation (espected average of 5 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522846
- Sponsor's protocol ID
- B_1112_069_003
- Status last verified
- Aug 2013
- First submitted
- 9 Jan 2012
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence by Heparinized Flush Solution of the Radial Artery Catheter: INTEM and HEPTEM Analysis.
- ClinicalTrials.gov ID
- NCT01522846
- Acronym / sponsor ID
- B_1112_069_003
- Conditions
- Brain Tumor, Spinal Stenosis, Cerebral Artery Anuerysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 1 Feb 2012 (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.
Heparinized solution has been used for maintenance of arterial catheter during perioperative period. Although the infused dose of heparin is very low, the investigators examine whether the heparin effect is remained or not in blood using rotational thromboelastometry (ROTEM) analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heparin | – | Drug: Heparin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring continuous invasive arterial pressure monitoring during operation for anesthetic management.
Key inclusion criteria (1 listed)
- Patients requiring continuous invasive arterial pressure monitoring during operation for anesthetic management.
Key exclusion criteria (3 listed)
- heparin hypersensitivity
- hematologic disease
- anticoagulant medication
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 |
|---|---|---|
| HeparinHeparinized flush solution contained heparin concentration of 2 unit/ml and continuous flow of the flush solution was 5 ml/h at 300 mmHg. | Drug | Heparin |
Primary outcome
INTEM test
Time frame: at 30 min before operation and 30 min after operation
INTEM is not an abbriviation. INTEM is one of the ROTEM test and it is an coagulation test name (such as prothrombin time test) using patient's whole blood. We put the blood sample of patinet into the machine, so the result comes out automatically. It will be checked twice at pre- and postopertive 30 minute and it'll be analyzed and compared.
HEPTEM test
Time frame: at 30 min before operation and 30 min after operation
HEPTEM is not an abbriviation. HEPTEM is one of the ROTEM test and it is an coagulation test name (such as prothrombin time test) using patient's whole blood. We put the blood sample of patinet into the machine, so the result comes out automatically. It will be checked twice at pre- and postopertive 30 minute and it'll be analyzed and compared.
1 secondary outcome
Total infused units of heparin
Time frame: periond from starting operation to finishing operation (espected average of 5 hours).
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 29 Aug 2013.
Related trials for Brain Tumor
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
Active, not recruitingObservational study
A Patient Registry of Patients With High-risk Neuroblastoma Being Treated With the Monoclonal Antibody Dinutuximab Beta
Neuroblastoma
Recruiting
Feasibility Assessment of Adapted Physical Activity in Patients Treated for a Brain Tumor
Brain Tumor Adult
RecruitingPhase 2
Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
Glioblastoma (GBM), Newly Diagnosed Glioblastoma
RecruitingPhase 2
A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
Meningioma
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 Brain Tumor and Spinal Stenosis, run by Seoul National University Bundang Hospital 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: finished, as of the sponsor's last update on 29 Aug 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?
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?
INTEM test (time frame: at 30 min before operation and 30 min after operation). The study lists 2 primary outcomes in all. 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 29 Aug 2013; AzTrials last refreshed its copy on 26 Oct 2026.