Two Monitors for Measuring the Activated Clotting Time: A Comparison

NCT03203148 | Completed

• 1 other identifier: 2017-HeartCentre-003
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Activated Clotting time

  Coagulation Measure

  Intraoperative

Secondary Outcomes (1)

• Anti-Factor Xa

  Intraoperative

Study Arms (1)

CABG Surgical Patients

Patients undergoing coronary bypass grafting with cardiopulmonary bypass

Diagnostic Test: Point-of-Care ACT

Interventions

Point-of-Care ACT DIAGNOSTIC_TEST

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

CABG Surgical Patients

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted for routine coronary bypass surgery with the use of cardiopulmonary bypass

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Heart Centre Umeå University Hospital

Umeå, S-901 85, Sweden

Location

Related Publications (5)

• 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.

  PMID: 1440486 BACKGROUND

• 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.

  PMID: 983997 BACKGROUND

• 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.

  PMID: 20519414 BACKGROUND

• 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.

  PMID: 15506033 BACKGROUND

• 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.

  PMID: 14604242 BACKGROUND

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Magnus Hedström, MD

  Heart Centre, Umeå University Hospital, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 29, 2017
• Study Start: April 18, 2017
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)