Blood Collections Via Peripheral IV CatheterNCT02747147
Multi-Day Evaluation of the TIVA Device
A study testing TIVA blood collection device in people with Blood Collections Via Peripheral IV Catheter, run by Velano Vascular, Inc. at 1 site in United States.
Trial summary
Prospective, randomized, single-center study to evaluate the ability of the device to collect good quality blood samples from patients with peripheral IV access over the length of their stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Collections Via Peripheral IV Catheter
- What is being tested?
- TIVA blood collection device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2016to 7 Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient will be admitted to the BWH unit 15 for post-surgical care
- Patient is at least 18 years old
- Patient is willing and physically / cognitively able to sign a written consent form
- Patient is willing and able to complete study questionnaires
- Patient is NOT a prisoner
Who cannot join
- Active hemodialysis
- Hemolytic disorders (e.g., sickle cell disease)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Prospective, randomized, single-center study to evaluate the ability of the device to collect good quality blood samples from patients with peripheral IV access over the length of their stay.
- Being tested
- TIVA blood collection device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIVA blood collection deviceDevice
the device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe
| Study group | Role | What they receive |
|---|---|---|
| A- Control | No intervention | Group A will have their PIVs assessed daily and record kept of PIV dislodgement or replacement |
| B - Device Intervention | Experimental | patients will have their PIVs assessed daily and record kept of PIV displodgement or replacement. patients will additionally have a single blood collection attempted using the study device Receives: Device: TIVA blood collection device |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Aspiration reliability
blood aspiration with the device is attempted once per day. The % of attempts that are successful will be reported across all attempts
Measured: up to 4 days after PIV placement
% of Specimen hemolyzed
each collected specimen will be analyzed for hemolysis. The hemolysis rate, or % of specimen that are hemolyzed will be reported over all collections.
Measured: up to 4 days
Secondary outcomes (1)
Avg PIV dwell - hours, mean, range
note hours between each PIV placement and removal for each patient. compare the the distribution of PIV dwell between the two arms
Measured: 1, 2, 3, and 4 calendar days after PIV placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start12 Apr 2016
- Primary completion21 Nov 2016
- Study completion7 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Collections Via Peripheral IV CatheterStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Velano Vascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deborah F Mulloy, PhD, RN, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747147
- Sponsor's protocol ID
- CP-004
- Status last verified
- May 2017
- First submitted
- 14 Apr 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Day Evaluation of the TIVA Device
- ClinicalTrials.gov ID
- NCT02747147
- Acronym / sponsor ID
- CP-004
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Velano Vascular, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 7 Dec 2016 (actual)
- First posted
- 21 Apr 2016 (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.
Prospective, randomized, single-center study to evaluate the ability of the device to collect good quality blood samples from patients with peripheral IV access over the length of their stay.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A- Control | No intervention | –Group A will have their PIVs assessed daily and record kept of PIV dislodgement or replacement |
| B - Device Intervention | Experimental | Device: TIVA blood collection devicepatients will have their PIVs assessed daily and record kept of PIV displodgement or replacement. patients will additionally have a single blood collection attempted using the study device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient will be admitted to the BWH unit 15 for post-surgical care
- Patient is at least 18 years old
- Patient is willing and physically / cognitively able to sign a written consent form
- Patient is willing and able to complete study questionnaires
- Patient is NOT a prisoner
Key exclusion criteria (3 listed)
- Active hemodialysis
- Hemolytic disorders (e.g., sickle cell disease)
- Pregnancy
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 |
|---|---|---|
| TIVA blood collection devicethe device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe | Device | B - Device Intervention |
Primary outcome
% Aspiration reliability
Time frame: up to 4 days after PIV placement
blood aspiration with the device is attempted once per day. The % of attempts that are successful will be reported across all attempts
% of Specimen hemolyzed
Time frame: up to 4 days
each collected specimen will be analyzed for hemolysis. The hemolysis rate, or % of specimen that are hemolyzed will be reported over all collections.
1 secondary outcome
Avg PIV dwell - hours, mean, range
Time frame: 1, 2, 3, and 4 calendar days after PIV placement
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 9 May 2017.
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.
Deborah F Mulloy, PhD, RN principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIVA blood collection device in people with Blood Collections Via Peripheral IV Catheter, run by Velano Vascular, 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 5 inclusion and 3 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 9 May 2017. 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?
% Aspiration reliability (time frame: up to 4 days after PIV placement). The study lists 2 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 9 May 2017.