QStat in Liver Transplant

NCT04114253 | Completed FDA Device

• 1 other identifier: HEMCS-029
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Loss, Surgical

Keywords

Viscoelastic testing; Coagulation; Quantra; Hemostasis

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• Comparison of Quantra Clot Time results to TEG R results

  Coagulation function assessed by Quantra and TEG 5000

  During surgery

• Comparison of Quantra Clot Stiffness results to TEG MA results

  Coagulation function assessed by Quantra and TEG 5000

  During surgery

• Comparison of Quantra Clot Lysis results to TEG LI30 results

  Coagulation function assessed by Quantra and TEG 5000

  During surgery

Study Arms (1)

Liver transplant patients

Adult patients undergoing deceased donor liver transplantation.

Diagnostic Test: Quantra System

Interventions

Quantra System DIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Also known as: Quantra QStat Cartridge

Liver transplant patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes subjects 18 years or older undergoing deceased donor liver transplant.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• HemoSonics LLC: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Blood Loss, Surgical; Thrombosis

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: September 4, 2019
• Primary Completion: August 12, 2020
• Study Completion: December 12, 2020
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)