Two Monitors for Measuring the Activated Clotting Time: A Comparison
Study Details
Study Description
Brief Summary
In this observational study a comparison is made between two different monitors for measurement of the activated clotting time (ACT): mechanical versus biochemical techniques
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The ACT is a functional test influenced by multiple factors, such as platelet function, coagulation factors, temperature and contact activation inhibitors. Results produced by different monitors are also prone to vary influenced by the specific method employed to perform the test.
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CABG Surgical Patients Patients undergoing coronary bypass grafting with cardiopulmonary bypass |
Diagnostic Test: Point-of-Care ACT
Comparison between two point-of-care devices for measurement of the activated clotting time
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Outcome Measures
Primary Outcome Measures
- Activated Clotting time [Intraoperative]
Coagulation Measure
Secondary Outcome Measures
- Anti-Factor Xa [Intraoperative]
Reference for heparin plasma concentration
Eligibility Criteria
Criteria
Inclusion Criteria: Patients listed for coronary bypass surgery, -
Exclusion Criteria: Primary coagulation disorder, diabetes mellitus, ongoing anti-coagulation therapy, emergency, reduced kidney function, allergy for fish, sea food and protamine
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Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Heart Centre Umeå University Hospital | Umeå | Sweden | S-901 85 |
Sponsors and Collaborators
- Umeå University
Investigators
- Study Director: Magnus Hedström, MD, Heart Centre, Umeå University Hospital, Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Hattersley PG. Progress report: the activated coagulation time of whole blood (ACT). Am J Clin Pathol. 1976 Nov;66(5):899-904.
- 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.
- Svenmarker S, Appelblad M, Jansson E, Häggmark S. Measurement of the activated clotting time during cardiopulmonary bypass: differences between Hemotec ACT and Hemochron Jr apparatus. Perfusion. 2004;19(5):289-94.
- 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.
- 2017-HeartCentre-003