Evaluation of a Device That Separates Blood Cells From Serum/Plasma
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 2/10/2019 |
| Start Date: | January 2016 |
| End Date: | May 2019 |
| Contact: | Michael F Holick, MD, PhD |
| Email: | mfholick@bu.edu |
| Phone: | 6176384546 |
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.
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.
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
;
1. Albumin
2. AlkalinePhosphatase
3. ALT (Alanine Transaminase)
4. AST (Aspartate Transaminase)
5. BUN (Blood Urea Nitrogen)
6. Creatinine
7. Glucose
8. Total Bilirubin
9. Total Protein
10. Calcium
11. Carbon Dioxide
12. Chloride
13. Potassium
14. Sodium
15. Troponin I
Furthermore, the BUN/Creatinine ratio shall also be presented in the data set.
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
;
1. Albumin
2. AlkalinePhosphatase
3. ALT (Alanine Transaminase)
4. AST (Aspartate Transaminase)
5. BUN (Blood Urea Nitrogen)
6. Creatinine
7. Glucose
8. Total Bilirubin
9. Total Protein
10. Calcium
11. Carbon Dioxide
12. Chloride
13. Potassium
14. Sodium
15. Troponin I
Furthermore, the BUN/Creatinine ratio shall also be presented in the data set.
Inclusion Criteria:
- at least 18 y/o
Exclusion Criteria:
We found this trial at
1
site
Boston, Massachusetts 02118
Phone: 617-638-4546
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