Two Monitors for Measuring the Activated Clotting Time: A Comparison

NCT ID: NCT03203148

Last Updated: 2023-05-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-18

Study Completion Date

2017-11-01

Brief Summary

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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

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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

Conditions

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Cardiopulmonary Bypass Blood Coagulation Point-of-Care Testing

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CABG Surgical Patients

Patients undergoing coronary bypass grafting with cardiopulmonary bypass

Point-of-Care ACT

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Sweden

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.

Reference Type BACKGROUND
PMID: 1440486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 983997 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20519414 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15506033 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14604242 (View on PubMed)

Other Identifiers

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2017-HeartCentre-003

Identifier Type: -

Identifier Source: org_study_id

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