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

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

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 surgery

Outcome measures

Outcome measures
Measure
All Patients
n=30 Participants
Kaolin-activated Clotting Time
309 seconds
Standard Deviation 211

SECONDARY outcome

Timeframe: Routine measurements during cardiac surgery

Outcome measures

Outcome 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

Director Clinical Trial

Triemli City Hospital

Phone: +41 44 416 25 52

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place