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Heparin Solution and INTEM/HEPTEM Analysis

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ClinicalTrials.gov Identifier: NCT01522846
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : August 29, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Brain Tumor Spinal Stenosis Cerebral Artery Anuerysm Drug: Heparin

Study Design

Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence by Heparinized Flush Solution of the Radial Artery Catheter: INTEM and HEPTEM Analysis.
Study Start Date : January 2012
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Heparin 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.


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Total infused units of heparin [ Time Frame: periond from starting operation to finishing operation (espected average of 5 hours). ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring continuous invasive arterial pressure monitoring during operation for anesthetic management.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • heparin hypersensitivity
  • hematologic disease
  • anticoagulant medication
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522846


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seonnam, Gyounggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
More Information

Responsible Party: Hyo-Seok Na, Assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01522846     History of Changes
Other Study ID Numbers: B_1112_069_003
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: August 29, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Pharmaceutical Solutions
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action