HemoSonics - UTMB Cardiac Surgery Study
1 other identifier
observational
30
1 country
1
Brief Summary
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra QPlus Cartridge in patients undergoing cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2019
CompletedFirst Posted
Study publicly available on registry
June 17, 2019
CompletedStudy Start
First participant enrolled
June 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2020
CompletedJuly 1, 2020
June 1, 2020
9 months
June 10, 2019
June 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
Comparison of Quantra Clot Time results to TEG R results
Coagulation function assessed by Quantra and TEG 5000
Baseline, defined as after induction of anesthesia but before surgical incision
Comparison of Quantra Clot Stiffness results to TEG MA results
Coagulation function assessed by Quantra and TEG 5000
Baseline, defined as after induction of anesthesia but before surgical incision
Comparison of Quantra Clot Time results to TEG R results
Coagulation function assessed by Quantra and TEG 5000
During bypass
Comparison of Quantra Clot Stiffness results to TEG MA results
Coagulation function assessed by Quantra and TEG 5000
During bypass
Comparison of Quantra Clot Time results to TEG R results
Coagulation function assessed by Quantra and TEG 5000
Post-bypass, defined as 10 to 20 minutes after protamine administration
Comparison of Quantra Clot Stiffness results to TEG MA results
Coagulation function assessed by Quantra and TEG 5000
Post-bypass, defined as 10 to 20 minutes after protamine administration
Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)
Coagulation function assessed by Quantra and standard coagulation tests
Baseline, defined as after induction of anesthesia but before surgical incision
Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results
Coagulation function assessed by Quantra and standard coagulation tests
Baseline, defined as after induction of anesthesia but before surgical incision
Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count
Coagulation function assessed by Quantra and standard coagulation tests
Baseline, defined as after induction of anesthesia but before surgical incision
Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)
Coagulation function assessed by Quantra and standard coagulation tests
During bypass
Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results
Coagulation function assessed by Quantra and standard coagulation tests
During bypass
Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count
Coagulation function assessed by Quantra and standard coagulation tests
During bypass
Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)
Coagulation function assessed by Quantra and standard coagulation tests
Post-bypass, defined as 10 to 20 minutes after protamine administration
Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results
Coagulation function assessed by Quantra and standard coagulation tests
Post-bypass, 10 to 20 minutes after protamine
Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count
Coagulation function assessed by Quantra and standard coagulation tests
Post-bypass, defined as 10 to 20 minutes after protamine administration
Study Arms (1)
Cardiac Surgery Patients
Patients undergoing cardiopulmonary bypass surgery, including placement of a ventricular access device.
Interventions
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Eligibility Criteria
The study population includes subjects 18 years or older undergoing cardiac surgery utilizing cardiopulmonary bypass, including placement of a ventricular access device.
You may qualify if:
- Subject is ≥ 18 years
- Subject is scheduled for cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.
- Subject is willing to participate, and he/she has signed a consent form.
You may not qualify if:
- Subject is younger than 18 years
- Subject is unable to provide written informed consent
- Subject is incarcerated at the time of the study
- Subject is pregnant
- Subject is currently enrolled in a distinct study that might confound the results of the proposed study
- Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HemoSonics LLClead
Study Sites (1)
University of Texas Medical Branch
Galveston, Texas, 77555, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2019
First Posted
June 17, 2019
Study Start
June 19, 2019
Primary Completion
March 13, 2020
Study Completion
May 15, 2020
Last Updated
July 1, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share