NCT02484157

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

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

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
Last Updated

June 29, 2015

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

June 25, 2015

Last Update Submit

June 26, 2015

Conditions

Keywords

Whole Blood Coagulation Timecardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Comparison of activated coagulation time between Hemochron Jr and ACT Plus

    During cardiac surgeris (within 8 hours)

Study Arms (1)

Patient

EXPERIMENTAL

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

Device: HemochronDevice: ACT Plus

Interventions

HemochronDEVICE

Activated coagulation time was checked serially by Hemochron Jr.

Patient
ACT PlusDEVICE

Activated coagulation time was checked serially by ACT Plus.

Patient

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent cardiac surgery with heparin administration.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, KS009, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 15506033BACKGROUND
  • 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.

    PMID: 19277416BACKGROUND
  • 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.

    PMID: 22534410BACKGROUND
  • 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.

    PMID: 16548858BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Soo Kyung Lee, MD

    Hallym University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2015

First Posted

June 29, 2015

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

June 29, 2015

Record last verified: 2012-12

Locations