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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01522846
Other study ID # B_1112_069_003
Secondary ID
Status Completed
Phase N/A
First received January 9, 2012
Last updated August 28, 2013
Start date January 2012
Est. completion date January 2013

Study information

Verified date August 2013
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Patients requiring continuous invasive arterial pressure monitoring during operation for anesthetic management.

Exclusion Criteria:

- heparin hypersensitivity

- hematologic disease

- anticoagulant medication

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Heparin
Heparinized flush solution contained heparin concentration of 2 unit/ml and continuous flow of the flush solution was 5 ml/h at 300 mmHg.

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seonnam Gyounggi

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. at 30 min before operation and 30 min after operation No
Primary 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. at 30 min before operation and 30 min after operation No
Secondary Total infused units of heparin periond from starting operation to finishing operation (espected average of 5 hours). No
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