Plasma ExtractionNCT02853448
Evaluation of a Device That Separates Blood Cells From Serum/Plasma
A study testing Novel Blood Drawing Apparatus in people with Plasma Extraction, run by Boston University at 1 site in United States.
Trial summary
There are many instances where there is no access to a centrifuge (Emergency wards, EMT truck, battle field, etc.) or when a result is needed immediately (myocardial infarction); a new collection tube which could separate serum and plasma from whole blood immediately upon, if not during, collection, would be extremely… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasma Extraction
- What is being tested?
- Novel Blood Drawing Apparatus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 20 Jun 2022
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 y/o
Who cannot join
- NONE
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Solomon Carter Fuller Mental Health Center, 85 E Newton St M-1013
Boston, Massachusetts, 02118
About this study
Official title: Evaluation of a Device That Separates Blood Cells From Serum/Plasma for Analysis of Clinical Chemistries
There are many instances where there is no access to a centrifuge (Emergency wards, EMT truck, battle field, etc.) or when a result is needed immediately (myocardial infarction); a new collection tube which could separate serum and plasma from whole blood immediately upon, if not during, collection, would be extremely beneficial. Such a new tube could save time and cost by eliminating centrifugation steps that are currently required to obtain serum and plasma.
Read the detailed description
A new blood collection tube has recently been developed; the tube separates serum/plasma from the whole blood while the blood flows into the tube. This is accomplished by a filter set inside the tube; the filter set may be impregnated with an anti coagulant agent, such as sodium citrate (blue top) or may be virgin (red top). The serum collection part of the tube is disconnected from the filtering part upon completion of the serum collection, capped with a lid, and forwarded to a bed-side instrument or to a test analysis laboratory. The filter part is discarded in a hazardous waste container. Blood Separation free of red cell damage is achieved by controlling blood flow rate into the device. A 30 second flow intake is typical. The flow rate controller in use in this experiment is an element added in line to the standard blood drawing needle set.
This study is being conducted to compare concentrations of routine clinical chemistries (analytes and electrolytes) measured in serum/plasma obtained from routine standard blood collection tubes to novel blood collection tubes that separate blood cells from whole blood while the blood is being drawn. Routine clinical labs will be performed on the serum and the plasma obtained from the standard and the novel tubes to evaluate the efficacy of the novel tubes to recover cell-free serum for measuring various routine blood analytes as compared to standard tubes.
Procedure Plasma, as well as serum, will be collected and analyzed in the study. While the blood collection procedures for each of these are the same, collection of blood into the standard tube differs from that into the serumSTAT tube; the subsequent post-treatment of the blood/serum/plasma differs from one to the other. The serum will be ready for analysis after completion of the steps. The procedure for how to draw the blood using the new device will be explained and demonstrated to the phlebotomist to ensure (s)he is comfortable using the device.
The following routine clinical chemistry shown in the metabolic panel below shall be measured ;
- Albumin
- AlkalinePhosphatase
- ALT (Alanine Transaminase)
- AST (Aspartate Transaminase)
- BUN (Blood Urea Nitrogen)
- Creatinine
- Glucose
- Total Bilirubin
- Total Protein
- Calcium
- Carbon Dioxide
- Chloride
- Potassium
- Sodium
- Troponin I
Furthermore, the BUN/Creatinine ratio shall also be presented in the data set.
- Conditions
- Plasma Extraction
- Being tested
- Novel Blood Drawing Apparatus
- Keywords
- Plasma, Serum, Effective Blood Draws
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Blood Drawing ApparatusDevice
| Study group | Role | What they receive |
|---|---|---|
| Novel Device | Experimental | Every Subject will be assigned to the same arm. This arm calls for blood to be drawn using an original blood drawing apparatus as well as using the novel blood drawing apparatus. Receives: Device: Novel Blood Drawing Apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with similar blood chemistry values for both blood drawing apparatuses
Test analysis will be done between blood chemistry values for both original and novel blood drawing apparatuses. Subject will have blood drawn once, and that blood will be used for a comparative analysis between the two blood drawing apparatuses. Thus, a time frame is N/A in this study.
Measured: At the time of blood analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJan 2016
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma ExtractionStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael F Holick, MD, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853448
- Sponsor's protocol ID
- H-32418
- Status last verified
- Jan 2023
- First submitted
- 27 Jul 2016
- Last updated
- 9 Jan 2023
- 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 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Device That Separates Blood Cells From Serum/Plasma for Analysis of Clinical Chemistries
- ClinicalTrials.gov ID
- NCT02853448
- Acronym / sponsor ID
- H-32418
- Conditions
- Plasma Extraction
- Keywords
- Plasma, Serum, Effective Blood Draws
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 3 Aug 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.
There are many instances where there is no access to a centrifuge (Emergency wards, EMT truck, battle field, etc.) or when a result is needed immediately (myocardial infarction); a new collection tube which could separate serum and plasma from whole blood immediately upon, if not during, collection, would be extremely beneficial. Such a new tube could save time and cost by eliminating centrifugation steps that are currently required to obtain serum and plasma.
Detailed description
A new blood collection tube has recently been developed; the tube separates serum/plasma from the whole blood while the blood flows into the tube. This is accomplished by a filter set inside the tube; the filter set may be impregnated with an anti coagulant agent, such as sodium citrate (blue top) or may be virgin (red top). The serum collection part of the tube is disconnected from the filtering part upon completion of the serum collection, capped with a lid, and forwarded to a bed-side instrument or to a test analysis laboratory. The filter part is discarded in a hazardous waste container. Blood Separation free of red cell damage is achieved by controlling blood flow rate into the device. A 30 second flow intake is typical. The flow rate controller in use in this experiment is an element added in line to the standard blood drawing needle set.
This study is being conducted to compare concentrations of routine clinical chemistries (analytes and electrolytes) measured in serum/plasma obtained from routine standard blood collection tubes to novel blood collection tubes that separate blood cells from whole blood while the blood is being drawn. Routine clinical labs will be performed on the serum and the plasma obtained from the standard and the novel tubes to evaluate the efficacy of the novel tubes to recover cell-free serum for measuring various routine blood analytes as compared to standard tubes.
Procedure Plasma, as well as serum, will be collected and analyzed in the study. While the blood collection procedures for each of these are the same, collection of blood into the standard tube differs from that into the serumSTAT tube; the subsequent post-treatment of the blood/serum/plasma differs from one to the other. The serum will be ready for analysis after completion of the steps. The procedure for how to draw the blood using the new device will be explained and demonstrated to the phlebotomist to ensure (s)he is comfortable using the device.
The following routine clinical chemistry shown in the metabolic panel below shall be measured ;
- Albumin
- AlkalinePhosphatase
- ALT (Alanine Transaminase)
- AST (Aspartate Transaminase)
- BUN (Blood Urea Nitrogen)
- Creatinine
- Glucose
- Total Bilirubin
- Total Protein
- Calcium
- Carbon Dioxide
- Chloride
- Potassium
- Sodium
- Troponin I
Furthermore, the BUN/Creatinine ratio shall also be presented in the data set.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel Device | Experimental | Device: Novel Blood Drawing ApparatusEvery Subject will be assigned to the same arm. This arm calls for blood to be drawn using an original blood drawing apparatus as well as using the novel blood drawing apparatus. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- at least 18 y/o
Key exclusion criteria (1 listed)
- NONE
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 |
|---|---|---|
| Novel Blood Drawing Apparatus | Device | Novel Device |
Primary outcome
Number of subjects with similar blood chemistry values for both blood drawing apparatuses
Time frame: At the time of blood analysis.
Test analysis will be done between blood chemistry values for both original and novel blood drawing apparatuses. Subject will have blood drawn once, and that blood will be used for a comparative analysis between the two blood drawing apparatuses. Thus, a time frame is N/A in this study.
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 Jan 2023.
- 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.
Michael F Holick, MD, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Blood Drawing Apparatus in people with Plasma Extraction, run by Boston University 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 1 inclusion and 1 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 Jan 2023. 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?
Number of subjects with similar blood chemistry values for both blood drawing apparatuses (time frame: At the time of blood analysis.). 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 Jan 2023.