Coagulation Defect; BleedingNCT06025708
Quantra QStat Sample Type Comparison
An observational study of Coagulation Defect; Bleeding, run by HemoSonics LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation Defect; Bleeding
- What is being tested?
- Diagnostic Test: Quantra QStat Cartridge
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing liver transplant surgery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Impact of Sample Type on the Performance of the Quantra QStat System
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.
Read the detailed description
In this single center prospective observational study, 25 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 75 matched samples for analysis on the Quantra System with the QStat Cartridge.
- Conditions
- Coagulation Defect; Bleeding
- Being tested
- Diagnostic Test: Quantra QStat Cartridge
- Keywords
- Quantra, Liver transplantation, Coagulation
- Medical subject headings
- Hemostatic Disorders, Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: Quantra QStat CartridgeDevice
Whole blood coagulation testing system
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of QStat Clot time (CT) in arterial and venous samples
Coagulation function assessed in two sample types
Measured: During liver transplantation surgery
Comparison of QStat Clot stiffness (CS) in arterial and venous samples
Coagulation function assessed in two sample types
Measured: 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
Measured: 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
Measured: During liver transplantation surgery
Comparison of QStat Clot Stabilty to Lysis (CSL) in arterial and venous samples
Coagulation function assessed in two sample types
Measured: During liver transplantation surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start11 Sep 2023
- Primary completion5 Jan 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation Defect; BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- HemoSonics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025708
- Sponsor's protocol ID
- HEMCS-046
- Status last verified
- May 2024
- First submitted
- 29 Aug 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sample Type on the Performance of the Quantra QStat System
- ClinicalTrials.gov ID
- NCT06025708
- Acronym / sponsor ID
- HEMCS-046
- Conditions
- Coagulation Defect; Bleeding
- Keywords
- Quantra, Liver transplantation, Coagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- HemoSonics LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this single center prospective observational study, 25 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 75 matched samples for analysis on the Quantra System with the QStat Cartridge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing liver transplant surgery.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: Quantra QStat CartridgeWhole blood coagulation testing system | Device | – |
Primary outcome
Comparison of QStat Clot time (CT) in arterial and venous samples
Time frame: During liver transplantation surgery
Coagulation function assessed in two sample types
Comparison of QStat Clot stiffness (CS) in arterial and venous samples
Time frame: During liver transplantation surgery
Coagulation function assessed in two sample types
Comparison of QStat Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples
Time frame: During liver transplantation surgery
Coagulation function assessed in two sample types
Comparison of QStat Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples
Time frame: During liver transplantation surgery
Coagulation function assessed in two sample types
Comparison of QStat Clot Stabilty to Lysis (CSL) in arterial and venous samples
Time frame: During liver transplantation surgery
Coagulation function assessed in two sample types
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation Defect; Bleeding, run by HemoSonics LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of QStat Clot time (CT) in arterial and venous samples (time frame: During liver transplantation surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.