Clinical trial NCT02484157: Comparison of ACT Between Hemochron Jr and ACT Plus
Official title: Comparison of Activated Coagulation Time Between Hemochron Jr and ACT Plus During Cardiac Surgery for Patient Using Acute Normovolemic Hemodilution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Keywords: Whole Blood Coagulation Time
cardiac surgery
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent cardiac surgery with heparin administration.

Exclusion Criteria:

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

Primary outcomes:
measure: Comparison of activated coagulation time between Hemochron Jr and ACT Plus
timeFrame: During cardiac surgeris (within 8 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
Study officials:
affiliation: Hallym University Medical Center
name: Soo Kyung Lee, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.