NCT01522846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

August 29, 2013

Status Verified

August 1, 2013

Enrollment Period

1 year

First QC Date

January 9, 2012

Last Update Submit

August 28, 2013

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • Total infused units of heparin

    periond from starting operation to finishing operation (espected average of 5 hours).

Study Arms (1)

Heparin

Drug: Heparin

Interventions

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

Heparin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • heparin hypersensitivity
  • hematologic disease
  • anticoagulant medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seonnam, Gyounggi, 463-707, South Korea

Location

MeSH Terms

Conditions

Brain NeoplasmsSpinal Stenosis

Interventions

Heparin

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 9, 2012

First Posted

February 1, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

August 29, 2013

Record last verified: 2013-08

Locations