An observational study in Blood Loss, Surgical, sponsored by HemoSonics LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-01.
Sponsored by HemoSonics LLC · Observational
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.
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, and ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra QPlus Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system.
This single-center, prospective, observational study will evaluate the performance of the Quantra System as compared to and comparable measures determined using the TEG 5000.
218 studies on the registry are indexed under Blood Loss, Surgical; 39 are open to participants now.
This study's enrollment of 30 is below the median of 154 across 49 observational studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →HemoSonics LLC is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population includes subjects 18 years or older undergoing cardiac surgery utilizing cardiopulmonary bypass, including placement of a ventricular access device.
Exclusion Criteria:
Patients undergoing cardiopulmonary bypass surgery, including placement of a ventricular access device.
Diagnostic Test: Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Also known as: Quantra QPlus Cartridge
Comparison of Quantra Clot Time results to TEG R results
Coagulation function assessed by Quantra and TEG 5000
Time frame: 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
Time frame: 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
Time frame: During bypass
Comparison of Quantra Clot Stiffness results to TEG MA results
Coagulation function assessed by Quantra and TEG 5000
Time frame: During bypass
Comparison of Quantra Clot Time results to TEG R results
Coagulation function assessed by Quantra and TEG 5000
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During bypass
Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results
Coagulation function assessed by Quantra and standard coagulation tests
Time frame: During bypass
Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count
Coagulation function assessed by Quantra and standard coagulation tests
Time frame: During bypass
Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)
Coagulation function assessed by Quantra and standard coagulation tests
Time frame: 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
Time frame: 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
Time frame: Post-bypass, defined as 10 to 20 minutes after protamine administration
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
HemoSonics LLC