NCT06025708

Brief Summary

This is a single center prospective observational study to compare QStat parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing liver transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

August 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

September 11, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

August 29, 2023

Last Update Submit

May 10, 2024

Conditions

Coagulation Defect; Bleeding

Keywords

QuantraLiver transplantationCoagulation

Outcome Measures

Primary Outcomes (5)

  • Comparison of QStat Clot time (CT) in arterial and venous samples

    Coagulation function assessed in two sample types

    During liver transplantation surgery

  • Comparison of QStat Clot stiffness (CS) in arterial and venous samples

    Coagulation function assessed in two sample types

    During liver transplantation surgery

  • Comparison of QStat Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples

    Coagulation function assessed in two sample types

    During liver transplantation surgery

  • Comparison of QStat Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples

    Coagulation function assessed in two sample types

    During liver transplantation surgery

  • Comparison of QStat Clot Stabilty to Lysis (CSL) in arterial and venous samples

    Coagulation function assessed in two sample types

    During liver transplantation surgery

Interventions

Diagnostic Test: Quantra QStat CartridgeDEVICE

Whole blood coagulation testing system

Eligibility Criteria

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

Adult patients undergoing liver transplant surgery.

You may qualify if:

  • Subject is \>=18 years
  • Subject is scheduled for liver transplant surgery
  • Subject or subject's legally authorized representative (LAR) is willing to provide 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 affected by a condition that, in the opinion of the treatment team, may pose additional risks
  • Subject, or subject's LAR, is unable or unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Hemostatic DisordersHemorrhageThrombosis

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and Thrombosis

Study Design

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

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 6, 2023

Study Start

September 11, 2023

Primary Completion

January 5, 2024

Study Completion

March 1, 2024

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)