N/A
N=52
Hemosonics- VCU Cardiac Surgery Clinical Study
Cardiopulmonary Bypass
Bottom Line
View on ClinicalTrials.gov: NCT02392247 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Clot Time — 4.9; 3.3 min — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Coagulation function (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clot Time |
4.9; 3.3 | <0.001 sig |
| PRIMARY Clot Stiffness |
8.5; 18.4 | <0.001 sig |
Summary
This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in cardiac surgery patients.
Eligibility Criteria
Inclusion Criteria
- Subject is scheduled for cardiac surgery involving bypass circuit
- Subject is older than 18 years
- Subject is willing to participate and he/she has signed a consent form
Exclusion Criteria
- Subject is unable to provide written informed consent
- Subject is incarcerated at the time of the study
- Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks
- Patients on emergency cases
Data sourced from ClinicalTrials.gov (NCT02392247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.