HealthyNCT02207205
Variability in the Measurement of WBCT Between Blood Drawn From Indwelling Catheters and Direct Venipuncture
A study testing Blood drawn from indwelling catheters versus direct venipuncture 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
1. Determine if there is any difference between the whole blood clotting time results obtained from blood drawn from indwelling catheters and direct venipuncture 2. Determine the intra-subject variability in both procedures 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?
- Blood drawn from indwelling catheters versus direct venipuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 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 (as determined by medical history) male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture.
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 drug (NSAID) or medications (including aspirin) 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
Duke Clinical Research Unit
Durham, North Carolina, 27710
About this study
Official title: A Study to Determine Variability in the Measurement of Whole Blood Clotting Time (WBCT) Between Blood Drawn From Indwelling Catheters and Direct Venipuncture
- Determine if there is any difference between the whole blood clotting time results obtained from blood drawn from indwelling catheters and direct venipuncture
- Determine the intra-subject variability in both procedures
Read the detailed description
No investigational products were administered to any subjects.
- Conditions
- Healthy
- Being tested
- Blood drawn from indwelling catheters versus direct venipuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawn from indwelling catheters versus direct venipunctureDrug
Evaluation of the source of blood samples on whole blood clotting time
| Study group | Role | What they receive |
|---|---|---|
| Catheter vs venipuncture blood samples | Other | Evaluation of whether there is any difference in results of whole blood clotting time in blood samples drawn from an indwelling catheter versus direct venipuncture Receives: Drug: Blood drawn from indwelling catheters versus direct venipuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole blood clotting time results from blood drawn from indwelling catheters and direct venipuncture
Comparison of results in whole blood clotting time from blood sampled by direct venipuncture and from indwelling catheters as assessed by multiple technicians
Measured: single day sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionJun 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
- 10 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
- Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Robert Noveck, MD, Principal investigator, Duke Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207205
- Sponsor's protocol ID
- PER977-01-006
- Status last verified
- Apr 2018
- First submitted
- 28 Jul 2014
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine Variability in the Measurement of Whole Blood Clotting Time (WBCT) Between Blood Drawn From Indwelling Catheters and Direct Venipuncture
- ClinicalTrials.gov ID
- NCT02207205
- Acronym / sponsor ID
- PER977-01-006
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Aug 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.
- Determine if there is any difference between the whole blood clotting time results obtained from blood drawn from indwelling catheters and direct venipuncture
- Determine the intra-subject variability in both procedures
Detailed description
No investigational products were administered to any subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheter vs venipuncture blood samples | Other | Drug: Blood drawn from indwelling catheters versus direct venipunctureEvaluation of whether there is any difference in results of whole blood clotting time in blood samples drawn from an indwelling catheter versus direct venipuncture |
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 (as determined by medical history) male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture.
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 |
|---|---|---|
| Blood drawn from indwelling catheters versus direct venipunctureEvaluation of the source of blood samples on whole blood clotting time | Drug | Catheter vs venipuncture blood samples |
Primary outcome
Whole blood clotting time results from blood drawn from indwelling catheters and direct venipuncture
Time frame: single day sampling
Comparison of results in whole blood clotting time from blood sampled by direct venipuncture and from indwelling catheters as assessed by multiple 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 4 Apr 2018.
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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.
Robert Noveck, MD principal investigator
Duke Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood drawn from indwelling catheters versus direct venipuncture 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 4 Apr 2018. 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?
Whole blood clotting time results from blood drawn from indwelling catheters and direct venipuncture (time frame: single day sampling). 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 4 Apr 2018.