Cardiac Surgical Procedure, Diagnostic Techniques and Procedures
Conditions
Keywords
Activated clotting time, Sonoclot
Brief 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.
Interventions
DEVICESonoclot Analyzer
Blood coagulation test during cardiac surgery: Measurement of activated clotting time during cardiac surgery by Sonoclot Analyzer
Sponsors
Triemli Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* all consecutive cardiac surgery patients
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kaolin-activated Clotting Time | Routine measurements during cardiac surgery |
Secondary
| Measure | Time frame |
|---|---|
| Glass Bead Activated Clotting Time | Routine measurements during cardiac surgery |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 15 |
| Region of Enrollment Switzerland | 30 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Kaolin-activated Clotting Time
Time frame: Routine measurements during cardiac surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Kaolin-activated Clotting Time | 309 seconds | Standard Deviation 211 |
Secondary
Glass Bead Activated Clotting Time
Time frame: Routine measurements during cardiac surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Glass Bead Activated Clotting Time | 195 seconds | Standard Deviation 57 |