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Completed

NCT Number: NCT03203148

Two Monitors for Measuring the Activated Clotting Time: A Comparison

In this observational study a comparison is made between two different monitors for measurement of the activated clotting time (ACT): mechanical versus biochemical techniques

Completed

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Key information

Conditions

Cardiopulmonary Bypass Blood Coagulation Cardiovascular Diseases Embolism and Thrombosis Point-of-Care Testing Thrombosis Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Centre Umeå University Hospital

Umeå, S-901 85, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Point-of-Care ACT

Diagnostic Test

Comparison between two point-of-care devices for measurement of the activated clotting time

Primary outcomes

  1. Activated Clotting time

    Time frame: Intraoperative

    Coagulation Measure

Secondary outcomes

  1. Anti-Factor Xa

    Time frame: Intraoperative

    Reference for heparin plasma concentration

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2017
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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