Evaluation of a Device That Separates Blood Cells From Serum/Plasma
Condition: Plasma Extraction
Study type: Interventional

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.
    

Intervention name(s): Novel Blood Drawing Apparatus
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Plasma; Serum; Effective Blood Draws