Heparin Solution and INTEM/HEPTEM Analysis

Brain Tumor Clinical Trial

Official title:

Influence by Heparinized Flush Solution of the Radial Artery Catheter: INTEM and HEPTEM Analysis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522846
• Other study ID #: B_1112_069_003
• 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

• Brain Tumor
• Cerebral Artery Anuerysm
• Spinal Stenosis

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