Evaluation of a New Sonoclot Device for Heparin Management in Cardiac Surgery

Diagnostic Techniques and Procedures Clinical Trial

— SONEW  

Official title:

Evaluation of a New Sonoclot Device for Heparin Management in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588976
• Other study ID #: STZ-Dendrite06
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: January 2011

Study information

• Verified date: April 2018
• Source: Triemli Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The SONOCLOT Analyzer (S1; Sienco, Inc. Boulder, CO USA, Model DP-2951) is used to perform kaolin-based activated clotting time as routine monitor of heparin therapy in patients undergoing cardiac operations. In addition, the device allows the assessment of the patient's coagulation status by a glass-bead activated test. Recently, a new SONOCLOT analyzer (S2) has been developed. As part of the routine management using S1, tests are also performed on S2. Results are entered into the cardiac surgery data base of all cardiac surgery patients and analyzed.

Description:

The SONOCLOT Analyzer (S1; Sienco, Inc. Boulder, CO USA, Model DP-2951) is used to routinely perform kaolin-based activated clotting time (kACT) as monitor of heparin therapy in patients undergoing cardiac operations on cardiopulmonary bypass.

Apart from kACT, the device allows the assessment of the patient's coagulation status by a glass-bead activated test (gbACT+, depicting also clot rate = CR and platelet function = PF). Recently, a new SONOCLOT analyzer (S2) has been developed. Although the S2 shares the technical fundamentals with the S1, the redesign of the device may result in performance changes of kACT and gbACT.

Routine management in cardiac surgery patients is guided using S1 and addition, tests are run on S2. Data are entered into the the cardiac surgery data base and S1 and S2 performance is compared by Bland-Altman analysis and % error calculation in order to establish new reference values.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• all consecutive cardiac surgery patients

Exclusion Criteria:

Related Conditions & MeSH terms

• Cardiac Surgical Procedure
• Diagnostic Techniques and Procedures

Intervention

Device:
• Sonoclot Analyzer
Blood coagulation test during cardiac surgery: Measurement of activated clotting time during cardiac surgery by Sonoclot Analyzer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Triemli Hospital

References & Publications (1)

Ganter MT, Hofer CK. Coagulation monitoring: current techniques and clinical use of viscoelastic point-of-care coagulation devices. Anesth Analg. 2008 May;106(5):1366-75. doi: 10.1213/ane.0b013e318168b367. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaolin-activated Clotting Time		Routine measurements during cardiac surgery
Secondary	Glass Bead Activated Clotting Time		Routine measurements during cardiac surgery