Trial Outcomes & Findings for Evaluation of a New Sonoclot Device for Heparin Management in Cardiac Surgery (NCT NCT02588976)
NCT ID: NCT02588976
Last Updated: 2018-05-04
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Routine measurements during cardiac surgery
Results posted on
2018-05-04
Participant Flow
Participant milestones
| Measure |
ACT Measurements
ACT measurements by SONOCLOT Analyzer during cardiac surgery
Sonoclot Analyzer: Blood coagulation test during cardiac surgery: Measurement of activated clotting time during cardiac surgery by Sonoclot Analyzer
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of a New Sonoclot Device for Heparin Management in Cardiac Surgery
Baseline characteristics by cohort
| Measure |
All Patients
n=30 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=93 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 15 • n=93 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
|
Region of Enrollment
Switzerland
|
30 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Routine measurements during cardiac surgeryOutcome measures
| Measure |
All Patients
n=30 Participants
|
|---|---|
|
Kaolin-activated Clotting Time
|
309 seconds
Standard Deviation 211
|
SECONDARY outcome
Timeframe: Routine measurements during cardiac surgeryOutcome measures
| Measure |
All Patients
n=30 Participants
|
|---|---|
|
Glass Bead Activated Clotting Time
|
195 seconds
Standard Deviation 57
|
Adverse Events
All Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place