HealthyNCT02205827
A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements
A study testing Single-arm in people with Healthy, run by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to characterize the distribution and sources of variability in whole blood clotting time (WBCT) measurements in human blood collected from healthy volunteers by 5 different technicians. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Single-arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2014
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed and dated, written informed consent (Institutional Review Board [IRB]-approved informed consent form [ICF]).
- Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)
Who cannot join
- Healthy subjects who do not conform to the above inclusion criteria.
- Healthy subjects who cannot communicate reliably with the Investigator.
- History of major bleeding or major trauma within the past 6 months
- Healthy volunteer with a propensity to bleed (i.e. due to recent trauma, recent surgery, peptic ulcer, active or recent gastrointestinal bleeding or bleeding from hemorrhoids).
- Significant infection or known inflammatory process within 2 weeks of screening.
- Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.
Show all 9Show fewer
- Received non-steroidal anti-inflammatory (NSAID) or medications (including any type of anticoagulant or aspirin [ASA]) with a direct effect on hemostasis within 7 days of testing
- Unwillingness or inability to comply with procedures required in this protocol.
- Subjects who are concurrently enrolled in any other clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Quintiles Phase I Services, LLC
Overland Park, Kansas, 66211
About this study
The purpose of the study is to characterize the distribution and sources of variability in whole blood clotting time (WBCT) measurements in human blood collected from healthy volunteers by 5 different technicians.
Read the detailed description
No investigational product was administered to any subject in this study.
- Conditions
- Healthy
- Being tested
- Single-arm
- Keywords
- whole blood clotting time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-armOther
Also called Whole Blood Clotting Time assessment
collection of blood for assessment of whole blood clotting time
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | No intervention | healthy volunteers Receives: Other: Single-arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability in whole blood clotting time measurement
Assessment of variability in whole blood clotting time measurements in human blood collected from volunteers in across five technicians
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- James Costin, MD, Study director, Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205827
- Sponsor's protocol ID
- PER977-01-005
- Status last verified
- Jul 2014
- First submitted
- 28 Jul 2014
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements
- ClinicalTrials.gov ID
- NCT02205827
- Acronym / sponsor ID
- PER977-01-005
- Conditions
- Healthy
- Keywords
- whole blood clotting time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 31 Jul 2014 (estimated)
- 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.
The purpose of the study is to characterize the distribution and sources of variability in whole blood clotting time (WBCT) measurements in human blood collected from healthy volunteers by 5 different technicians.
Detailed description
No investigational product was administered to any subject in this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | No intervention | Other: Single-armhealthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed and dated, written informed consent (Institutional Review Board [IRB]-approved informed consent form [ICF]).
- Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)
Key exclusion criteria (9 listed)
- Healthy subjects who do not conform to the above inclusion criteria.
- Healthy subjects who cannot communicate reliably with the Investigator.
- History of major bleeding or major trauma within the past 6 months
- Healthy volunteer with a propensity to bleed (i.e. due to recent trauma, recent surgery, peptic ulcer, active or recent gastrointestinal bleeding or bleeding from hemorrhoids).
- Significant infection or known inflammatory process within 2 weeks of screening.
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 |
|---|---|---|
| Single-armAlso: Whole Blood Clotting Time assessmentcollection of blood for assessment of whole blood clotting time | Other | Single-arm |
Primary outcome
Variability in whole blood clotting time measurement
Time frame: 1 day
Assessment of variability in whole blood clotting time measurements in human blood collected from volunteers in across five technicians
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 20 May 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.
James Costin, MD study director
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-arm in people with Healthy, run by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. 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 2 inclusion and 9 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 20 May 2020. 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?
Variability in whole blood clotting time measurement (time frame: 1 day). 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 20 May 2020.