QStat in Liver Transplant

Blood Loss, Surgical Clinical Trial

Official title:

Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Liver Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04114253
• Other study ID #: HEMCS-029
• Status: Completed
• Start date: September 4, 2019
• Est. completion date: December 12, 2020

Study information

• Verified date: December 2020
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will assess the clinical performance of the Quantra System with the QStat Cartridge in the liver transplant population.

Description:

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic propoerties of a whole blood sample during coagulation. The Quantra QStat Cartridge was developed to monitor hemostasis in the trauma and liver transplant populations which may experience a range of coagulopathies of various etiologies including fibrinolytic defects. This single-center, prospective, observational stuey will evaluate the performance of the Quantra System with the QStat Cartridge as compared to corresponding measures determined using the TEG 5000.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 12, 2020
• Est. primary completion date: August 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is = 18 years of age
• Subject is undergoing deceased donor liver transplant and is a candidate for a TEG test to be performed to access coagulopathy during surgery.
• Subject is willing to participate, and is willing to consent (either prospectively or by deferred consent)

Exclusion Criteria:

• Subject is younger than 18 years of age
• Subject is known to have received antifibrinolytic therapy immediately prior to the start of liver transplantation surgery.
• Subject is unable to provide written informed consent (either prior to performing any study related procedures or by deferred consent)
• 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

Related Conditions & MeSH terms

• Blood Loss, Surgical

Intervention

Diagnostic Test:
• Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HemoSonics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Quantra Clot Time results to TEG R results	Coagulation function assessed by Quantra and TEG 5000	Baseline, after induction of anesthesia, before surgical incision
Primary	Comparison of Quantra Clot Stiffness results to TEG MA results	Coagulation function assessed by Quantra and TEG 5000	Baseline, after induction of anesthesia, before surgical incision
Primary	Comparison of Quantra Clot Lysis results to TEG LI30 results	Coagulation function assessed by Quantra and TEG 5000	Baseline, after induction of anesthesia, before surgical incision
Primary	Comparison of Quantra Clot Time results to TEG R results	Coagulation function assessed by Quantra and TEG 5000	During surgery
Primary	Comparison of Quantra Clot Stiffness results to TEG MA results	Coagulation function assessed by Quantra and TEG 5000	During surgery
Primary	Comparison of Quantra Clot Lysis results to TEG LI30 results	Coagulation function assessed by Quantra and TEG 5000	During surgery