Cardiac DiseaseNCT02484157
Comparison of ACT Between Hemochron Jr and ACT Plus
A study testing Hemochron and ACT Plus in people with Cardiac Disease, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
This study aimed to compare 2 activated clotting time analysers (Hemochron Jr vs. ACT Plus). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Hemochron and ACT Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent cardiac surgery with heparin administration.
Who cannot join
- Preoperative hemoglobin under 11g/dL
- Weight under 40kg
- Preoperative coagulopathy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, KS009
About this study
Official title: 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).
Read the 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.
- Conditions
- Cardiac Disease
- Being tested
- Hemochron, ACT Plus
- Keywords
- Whole Blood Coagulation Time, cardiac surgery
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemochronDevice
Activated coagulation time was checked serially by Hemochron Jr.
ACT PlusDevice
Activated coagulation time was checked serially by ACT Plus.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Patients were checked activated coagulation time by both Hemochron Jr and ACT Plus during cardiac surgery with heparin administration. Receives: Device: Hemochron; Device: ACT Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of activated coagulation time between Hemochron Jr and ACT Plus
Measured: During cardiac surgeris (within 8 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soo Kyung Lee, MD, Study chair, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484157
- Sponsor's protocol ID
- 2012-I0814
- Status last verified
- Dec 2012
- First submitted
- 25 Jun 2015
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15506033Chia 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.
PubMed 19277416Bosch 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.
PubMed 22534410Dalbert 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.
PubMed 16548858
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Activated Coagulation Time Between Hemochron Jr and ACT Plus During Cardiac Surgery for Patient Using Acute Normovolemic Hemodilution
- ClinicalTrials.gov ID
- NCT02484157
- Acronym / sponsor ID
- 2012-I0814
- Conditions
- Cardiac Disease
- Keywords
- Whole Blood Coagulation Time, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Device: Hemochron, Device: ACT PlusPatients were checked activated coagulation time by both Hemochron Jr and ACT Plus during cardiac surgery with heparin administration. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who underwent cardiac surgery with heparin administration.
Key exclusion criteria (3 listed)
- Preoperative hemoglobin under 11g/dL
- Weight under 40kg
- Preoperative coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemochronActivated coagulation time was checked serially by Hemochron Jr. | Device | Patient |
| ACT PlusActivated coagulation time was checked serially by ACT Plus. | Device | Patient |
Primary outcome
Comparison of activated coagulation time between Hemochron Jr and ACT Plus
Time frame: During cardiac surgeris (within 8 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
- Background: PubMed 15506033Svenmarker 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.
- Background: PubMed 19277416Chia 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.
- Background: PubMed 22534410Bosch 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.
- Background: PubMed 16548858Dalbert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soo Kyung Lee, MD study chair
Hallym University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemochron and ACT Plus in people with Cardiac Disease, run by Hallym University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of activated coagulation time between Hemochron Jr and ACT Plus (time frame: During cardiac surgeris (within 8 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484157, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.