NCT04312958

Brief Summary

This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
397

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

2.4 years

First QC Date

March 15, 2020

Last Update Submit

April 28, 2023

Conditions

HemorrhageTraumaLiver Transplant

Keywords

Viscoelastic testingCoagulationTraumaLiver TransplantQuantraQStat

Outcome Measures

Primary Outcomes (16)

  • Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results

    Coagulation function assessed by Quantra and ROTEM Delta

    Upon arrival of trauma subject to the emergency department

  • Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results

    Coagulation function assessed by Quantra and ROTEM Delta

    Baseline, immediately before the start of liver transplant surgery

  • Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results

    Coagulation function assessed by Quantra and ROTEM Delta

    During anhepatic phase of liver transplant surgery

  • Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results

    Coagulation function assessed by Quantra and ROTEM Delta

    During post-reperfusion phase of liver transplant surgery

  • Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results

    Coagulation function assessed by Quantra and ROTEM Delta

    Upon arrival of trauma subject to the emergency department

  • Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results

    Coagulation function assessed by Quantra and ROTEM Delta

    Baseline, immediately before the start of liver transplant surgery

  • Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results

    Coagulation function assessed by Quantra and ROTEM Delta

    During anhepatic phase of liver transplant surgery

  • Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results

    Coagulation function assessed by Quantra and ROTEM Delta

    During post-reperfusion phase of liver transplant surgery

  • Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results

    Coagulation function assessed by Quantra and ROTEM Delta

    Upon arrival of trauma subject to the emergency department

  • Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results

    Coagulation function assessed by Quantra and ROTEM Delta

    Baseline, immediately before the start of liver transplant surgery

  • Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results

    Coagulation function assessed by Quantra and ROTEM Delta

    During anhepatic phase of liver transplant surgery

  • Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results

    Coagulation function assessed by Quantra and ROTEM Delta

    During post-reperfusion phase of liver transplant surgery

  • Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results

    Coagulation function assessed by Quantra and ROTEM Delta

    Upon arrival of trauma subject to the emergency department

  • Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results

    Coagulation function assessed by Quantra and ROTEM Delta

    Baseline, immediately before the start of liver transplant surgery

  • Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results

    Coagulation function assessed by Quantra and ROTEM Delta

    During anhepatic phase of liver transplant surgery

  • Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results

    Coagulation function assessed by Quantra and ROTEM Delta

    During post-reperfusion phase of liver transplant surgery

Study Arms (2)

Trauma patients

Trauma patients experiencing traumatic injuries requiring a full trauma team response.

Diagnostic Test: Quantra System

Liver transplant patients

Patients undergoing liver transplant surgery.

Diagnostic Test: Quantra System

Interventions

Quantra SystemDIAGNOSTIC_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 patientsTrauma patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Potential study participants will be adult (\>18 years) trauma patients or patients undergoing liver transplant surgery.

You may qualify if:

  • Subject is \> 18 years
  • Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response OR Subject is a patient undergoing liver transplant surgery.
  • Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent, OR Institutional Review Board (IRB)/Ethics Committee (EC) has waived the requirement to obtain informed consent.

You may not qualify if:

  • Subject is younger than 18 years of age
  • Subject is pregnant.
  • Subject is incarcerated at the time of the study.
  • Subject is currently enrolled in a distinct study that might confound the result of the proposed study
  • Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

Location

University of Colorado

Denver, Colorado, 28037, United States

Location

University of Florida Health Shands Hospital

Gainesville, Florida, 32608, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 98109, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Oklahoma Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Texas Tech University Health Sciences Center

El Paso, Texas, 79905, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

  • Moore EE, Michelson EA, Gabriel-Ramos K, Cripps MW, Flores A, Vandyck K, Thurston B, Brennan M, Viola F, Winegar DA. Multicenter evaluation of the Quantra with the QStat Cartridge in adult trauma patients. Trauma Surg Acute Care Open. 2025 Jun 3;10(2):e001672. doi: 10.1136/tsaco-2024-001672. eCollection 2025.

    PMID: 40486089DERIVED

MeSH Terms

Conditions

HemorrhageWounds and InjuriesThrombosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

March 15, 2020

First Posted

March 18, 2020

Study Start

July 20, 2020

Primary Completion

December 31, 2022

Study Completion

April 13, 2023

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(10)