Clinical trial NCT02853448: Evaluation of a Device That Separates Blood Cells From Serum/Plasma
Official title: Evaluation of a Device That Separates Blood Cells From Serum/Plasma for Analysis of Clinical Chemistries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plasma Extraction
Keywords: Plasma
Serum
Effective Blood Draws
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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 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 ;

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.

Eligibility criteria: Inclusion Criteria:

* at least 18 y/o

Exclusion Criteria:

* NONE

Primary outcomes:
measure: Number of subjects with similar blood chemistry values for both blood drawing apparatuses
timeFrame: At the time of blood analysis.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dr. Solomon Carter Fuller Mental Health Center, 85 E Newton St M-1013
state: Massachusetts
Study officials:
affiliation: Boston University
name: Michael F Holick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: