Heparin Solution and INTEM/HEPTEM Analysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01522846
First received: January 9, 2012
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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 Intervention
Brain Tumor
Spinal Stenosis
Cerebral Artery Anuerysm
Drug: Heparin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence by Heparinized Flush Solution of the Radial Artery Catheter: INTEM and HEPTEM Analysis.

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • INTEM test [ Time Frame: at 30 min before operation and 30 min after operation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Total infused units of heparin [ Time Frame: periond from starting operation to finishing operation (espected average of 5 hours). ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 9, 2012
Last Updated: August 28, 2013
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Brain Neoplasms
Spinal Stenosis
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Calcium heparin
Heparin
Pharmaceutical Solutions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 14, 2014