Skip to main content
Clinical Trials/NCT03203148
NCT03203148
Completed
Not Applicable

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

Umeå University1 site in 1 country20 target enrollmentApril 18, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiopulmonary Bypass
Sponsor
Umeå University
Enrollment
20
Locations
1
Primary Endpoint
Activated Clotting time
Status
Completed
Last Updated
2 years ago

Overview

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

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

Registry
clinicaltrials.gov
Start Date
April 18, 2017
End Date
November 1, 2017
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Activated Clotting time

Time Frame: Intraoperative

Coagulation Measure

Secondary Outcomes

  • Anti-Factor Xa(Intraoperative)

Study Sites (1)

Loading locations...

Similar Trials