Evaluation of a Device That Separates Blood Cells From Serum/Plasma

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.

Study Overview

• Status: Completed
• Conditions: Plasma Extraction
• Intervention / Treatment: Device: Novel Blood Drawing Apparatus

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Dr. Solomon Carter Fuller Mental Health Center, 85 E Newton St M-1013

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• at least 18 y/o

Exclusion Criteria:

• NONE

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novel Device; 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.	Device: Novel Blood Drawing Apparatus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the time of blood analysis.

Collaborators and Investigators

• Sponsor: Boston University
• Investigators: Principal Investigator: Michael F Holick, MD, PhD, Boston University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 20, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (Estimate): August 3, 2016

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Serum; Plasma; Effective Blood Draws
• Other Study ID Numbers: H-32418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes