Two Monitors for Measuring the Activated Clotting Time: A Comparison

Cardiopulmonary Bypass Clinical Trial

Official title:

Comparison of Two Point of Care Techniques Mechanical Versus Biochemical Activated Clotting Time

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203148
• Other study ID #: 2017-HeartCentre-003
• Status: Completed
• Start date: April 18, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: May 2023
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Blood Coagulation
• Cardiopulmonary Bypass
• Point-of-Care Testing

Intervention

Diagnostic Test:
• Point-of-Care ACT
Comparison between two point-of-care devices for measurement of the activated clotting time

Locations

Country	Name	City	State
Sweden	Heart Centre Umeå University Hospital	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activated Clotting time	Coagulation Measure	Intraoperative
Secondary	Anti-Factor Xa	Reference for heparin plasma concentration	Intraoperative