Two Monitors for Measuring the Activated Clotting Time: A Comparison
NCT ID: NCT03203148
Last Updated: 2023-05-12
Study Results
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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COMPLETED
20 participants
OBSERVATIONAL
2017-04-18
2017-11-01
Brief Summary
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Detailed Description
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The present clinical study aims to compare two types of ACT monitors: the Hemostatic Management System Plus (Medtronic) and i-STAT (Abbott) in 20 cardiac surgical patients by performing five intraoperative consecutive measurements using anti factor Xa as a reference for the actual heparin concentration.
Inclusion criteria comprised patients aged 20-80 years, scheduled for coronary bypass surgery.
Measurements: 1) before induction of anaesthesia 2 ) after heparin bolus 3) rewarming of the patient 4) weaning from cardiopulmonary bypass 5) after protamine administration.
The Hemostatic System Plus ACT monitor served as reference for dosing of heparin in all patients. The study protocol did not intervene with the standard protocol used for anticoagulation. No patient interventions were made.
It is hypothesised that the i-STAT ACT monitor has a better correlation with the actual heparin concentration than the Hemostatic Management System Plus
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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CABG Surgical Patients
Patients undergoing coronary bypass grafting with cardiopulmonary bypass
Point-of-Care ACT
Comparison between two point-of-care devices for measurement of the activated clotting time
Interventions
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Point-of-Care ACT
Comparison between two point-of-care devices for measurement of the activated clotting time
Eligibility Criteria
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Exclusion Criteria
20 Years
80 Years
ALL
No
Sponsors
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Umeå University
OTHER
Responsible Party
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Principal Investigators
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Magnus Hedström, MD
Role: STUDY_DIRECTOR
Heart Centre, Umeå University Hospital, Sweden
Locations
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Heart Centre Umeå University Hospital
Umeå, , Sweden
Countries
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References
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Teufelsbauer H, Proidl S, Havel M, Vukovich T. Early activation of hemostasis during cardiopulmonary bypass: evidence for thrombin mediated hyperfibrinolysis. Thromb Haemost. 1992 Sep 7;68(3):250-2.
Hattersley PG. Progress report: the activated coagulation time of whole blood (ACT). Am J Clin Pathol. 1976 Nov;66(5):899-904. doi: 10.1093/ajcp/66.5.899.
Guzzetta NA, Monitz HG, Fernandez JD, Fazlollah TM, Knezevic A, Miller BE. Correlations between activated clotting time values and heparin concentration measurements in young infants undergoing cardiopulmonary bypass. Anesth Analg. 2010 Jul;111(1):173-9. doi: 10.1213/ANE.0b013e3181e13470. Epub 2010 Jun 2.
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.
Raymond PD, Ray MJ, Callen SN, Marsh NA. Heparin monitoring during cardiac surgery. Part 1: Validation of whole-blood heparin concentration and activated clotting time. Perfusion. 2003 Sep;18(5):269-76. doi: 10.1191/0267659103pf672oa.
Other Identifiers
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2017-HeartCentre-003
Identifier Type: -
Identifier Source: org_study_id
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