CoagulationNCT03133351
Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM™) in Healthy Volunteers
An observational study of Coagulation, run by Entegrion, Inc. at 2 sites in United States.
Trial summary
This study is intended to define the PCM normal laboratory range. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coagulation
- What is being tested?
- PCM
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Apr 2017to 31 Mar 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Age ≥ 18 years old
- Body Mass Index (BMI) ≥ 19 and ≤ 30 kg/m2m with body weight ≥ 50 kg (106 lb)
- Normal vital signs at screening
Who cannot join
- Current daily tobacco use or previous recreational drug use
- Pregnant or lactating at the time of the study
- Currently taking any medications known to affect coagulation
- History of excessive bleeding from minor trauma that required medical attention, spontaneous nose bleeds that required medical attention or multiple spontaneous abortions, liver disease, blood related diseases, congenital or acquired coagulopathies or thromboembolic diseases
- Current diagnosis of cancer
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
This study is intended to define the PCM normal laboratory range.
- Conditions
- Coagulation
- Being tested
- PCM
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCMDevice
Also called Point of Care Coagulation Monitor
A fresh whole blood sample will be tested by PCM to determine the reference range.
| Study group | Role | What they receive |
|---|---|---|
| PCM | All enrolled subjects will have a blood sample tested using PCM. Receives: Device: PCM |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCM Clotting Time (CT)
To define the PCM normal laboratory reference range, PCM clotting time (CT) will be measured.
Measured: Testing to be initiated within 4 minutes of sample collection
Clot Formation Time (CFT)
To define the PCM normal laboratory reference range, clot formation time (CFT) will be measured.
Measured: Testing to be initiated within 4 minutes of sample collection
Alpha Angle (AA)
To define the PCM normal laboratory reference range, alpha angle (AA) will be measured.
To define the PCM normal laboratory reference range, clot formation time (CFT) will be measured.
Measured: Testing to be initiated within 4 minutes of sample collection
Maximum Clot Firmness (MCF)
To define the PCM normal laboratory reference range, maximum clot firmness (MCF) will be measured.
Measured: Testing to be initiated within 4 minutes of sample collection
30-minutes Lysis after CT (LI30)
To define the PCM normal laboratory reference range, 30-minutes lysis after CT (LI30) will be measured.
Measured: Testing to be initiated with 4 minutes of sample collection, with result available 30 minutes after CT
45-minutes Lysis after CT (LI45)
To define the PCM normal laboratory reference range, 45-minutes lysis after CT (LI45) will be measured.
Measured: Testing to be initiated within 4 minutes of sample collection, with result available 45 minutes after CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start4 Apr 2017
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulationStudies 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Entegrion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133351
- Sponsor's protocol ID
- PCM-001
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2017
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM™) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03133351
- Acronym / sponsor ID
- PCM-001
- Conditions
- Coagulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Entegrion, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 28 Apr 2017 (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 study is intended to define the PCM normal laboratory range.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCM | – | Device: PCMAll enrolled subjects will have a blood sample tested using PCM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Body Mass Index (BMI) ≥ 19 and ≤ 30 kg/m2m with body weight ≥ 50 kg (106 lb)
- Normal vital signs at screening
Key exclusion criteria (5 listed)
- Current daily tobacco use or previous recreational drug use
- Pregnant or lactating at the time of the study
- Currently taking any medications known to affect coagulation
- History of excessive bleeding from minor trauma that required medical attention, spontaneous nose bleeds that required medical attention or multiple spontaneous abortions, liver disease, blood related diseases, congenital or acquired coagulopathies or thromboembolic diseases
- Current diagnosis of cancer
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 |
|---|---|---|
| PCMAlso: Point of Care Coagulation MonitorA fresh whole blood sample will be tested by PCM to determine the reference range. | Device | PCM |
Primary outcome
PCM Clotting Time (CT)
Time frame: Testing to be initiated within 4 minutes of sample collection
To define the PCM normal laboratory reference range, PCM clotting time (CT) will be measured.
Clot Formation Time (CFT)
Time frame: Testing to be initiated within 4 minutes of sample collection
To define the PCM normal laboratory reference range, clot formation time (CFT) will be measured.
Alpha Angle (AA)
Time frame: Testing to be initiated within 4 minutes of sample collection
To define the PCM normal laboratory reference range, alpha angle (AA) will be measured. To define the PCM normal laboratory reference range, clot formation time (CFT) will be measured.
Maximum Clot Firmness (MCF)
Time frame: Testing to be initiated within 4 minutes of sample collection
To define the PCM normal laboratory reference range, maximum clot firmness (MCF) will be measured.
30-minutes Lysis after CT (LI30)
Time frame: Testing to be initiated with 4 minutes of sample collection, with result available 30 minutes after CT
To define the PCM normal laboratory reference range, 30-minutes lysis after CT (LI30) will be measured.
45-minutes Lysis after CT (LI45)
Time frame: Testing to be initiated within 4 minutes of sample collection, with result available 45 minutes after CT
To define the PCM normal laboratory reference range, 45-minutes lysis after CT (LI45) will be measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation, run by Entegrion, Inc. at 2 sites 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: status not confirmed, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
PCM Clotting Time (CT) (time frame: Testing to be initiated within 4 minutes of sample collection). The study lists 6 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 16 Apr 2020.