Comparison of ACT Between Hemochron Jr and ACT Plus

NCT ID: NCT02484157

Last Updated: 2015-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cardiac Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Patient

Patients were checked activated coagulation time by both Hemochron Jr and ACT Plus during cardiac surgery with heparin administration.

Group Type EXPERIMENTAL

Hemochron

Intervention Type DEVICE

Activated coagulation time was checked serially by Hemochron Jr.

ACT Plus

Intervention Type DEVICE

Activated coagulation time was checked serially by ACT Plus.

Interventions

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Hemochron

Activated coagulation time was checked serially by Hemochron Jr.

Intervention Type DEVICE

ACT Plus

Activated coagulation time was checked serially by ACT Plus.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent cardiac surgery with heparin administration.

Exclusion Criteria

* Preoperative hemoglobin under 11g/dL
* Weight under 40kg
* Preoperative coagulopathy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hallym University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Soo Kyung Lee, MD

Role: STUDY_CHAIR

Hallym University Medical Center

Locations

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Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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Svenmarker S, Appelblad M, Jansson E, Haggmark S. Measurement of the activated clotting time during cardiopulmonary bypass: differences between Hemotec ACT and Hemochron Jr apparatus. Perfusion. 2004;19(5):289-94. doi: 10.1191/0267659104pf755oa.

Reference Type BACKGROUND
PMID: 15506033 (View on PubMed)

Chia S, Van Cott EM, Raffel OC, Jang IK. Comparison of activated clotting times obtained using Hemochron and Medtronic analysers in patients receiving anti-thrombin therapy during cardiac catheterisation. Thromb Haemost. 2009 Mar;101(3):535-40.

Reference Type BACKGROUND
PMID: 19277416 (View on PubMed)

Bosch YP, Weerwind PW, Nelemans PJ, Maessen JG, Mochtar B. An evaluation of factors affecting activated coagulation time. J Cardiothorac Vasc Anesth. 2012 Aug;26(4):563-8. doi: 10.1053/j.jvca.2012.03.011. Epub 2012 Apr 24.

Reference Type BACKGROUND
PMID: 22534410 (View on PubMed)

Dalbert S, Ganter MT, Furrer L, Klaghofer R, Zollinger A, Hofer CK. Effects of heparin, haemodilution and aprotinin on kaolin-based activated clotting time: in vitro comparison of two different point of care devices. Acta Anaesthesiol Scand. 2006 Apr;50(4):461-8. doi: 10.1111/j.1399-6576.2006.00990.x.

Reference Type BACKGROUND
PMID: 16548858 (View on PubMed)

Other Identifiers

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2012-I0814

Identifier Type: -

Identifier Source: org_study_id

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