NCT02588976

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Triemli Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diagnostic Techniques and Procedures
• Cardiac Surgical Procedure

Interventions

Type	Name	Description
DEVICE	Sonoclot Analyzer	Blood coagulation test during cardiac surgery: Measurement of activated clotting time during cardiac surgery by Sonoclot Analyzer

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-01-01
• Completion: 2011-01-01
• First posted: 2015-10-28
• Last updated: 2018-05-04
• Results posted: 2018-04-03