Comparison of ACT Between Hemochron Jr and ACT Plus

June 26, 2015 updated by: Hallym University Medical Center

Comparison of Activated Coagulation Time Between Hemochron Jr and ACT Plus During Cardiac Surgery for Patient Using Acute Normovolemic Hemodilution

This study aimed to compare 2 activated clotting time analysers (Hemochron Jr vs. ACT Plus).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Measurement of activated clotting time (ACT) is a standard method for anticoagulation monitoring. Especially in cardiac surgery, heparin is usually used as anticoagulant and protamine is used to reverse anticoagulation effect at the end of surgery. ACT method defines the time until a clot is formed in a test tube after triggering of internal pathway coagulation using blood activating agents (eg. kaolin).

Acute normovolemic hemodilution (ANH) consists of withdrawing patient's blood volume early in the operative period and concurrent infusion of crystalloid or colloid to maintain intravascular volume, and is used in cardiac surgery. ANH is known to affect hemostasis in some studies.

Assuming that accurate monitoring of coagulation therapy is important to prevent both thrombotic and hemorrhagic complications, we compared ACT results from 2 analysers (Hemochron Jr and ACT Plus) in patients undergoing cardiac surgery using ANH.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, Republic of, KS009
        • Hallym University Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who underwent cardiac surgery with heparin administration.

Exclusion Criteria:

  • Preoperative hemoglobin under 11g/dL
  • Weight under 40kg
  • Preoperative coagulopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient
Patients were checked activated coagulation time by both Hemochron Jr and ACT Plus during cardiac surgery with heparin administration.
Device: Hemochron
Activated coagulation time was checked serially by Hemochron Jr.
Device: ACT Plus
Activated coagulation time was checked serially by ACT Plus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of activated coagulation time between Hemochron Jr and ACT Plus
Time Frame: During cardiac surgeris (within 8 hours)
During cardiac surgeris (within 8 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Medical Center

Investigators

  • Study Chair: Soo Kyung Lee, MD, Hallym University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

June 29, 2015

Study Record Updates

Last Update Posted (Estimate)

June 29, 2015

Last Update Submitted That Met QC Criteria

June 26, 2015

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-I0814

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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