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

NCT ID: NCT02853448

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2022-06-20

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.

Conditions

Plasma Extraction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Novel Blood Drawing Apparatus

Intervention Type: DEVICE

Interventions

Novel Blood Drawing Apparatus

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• at least 18 y/o

Exclusion Criteria

• NONE

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael F Holick, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Dr. Solomon Carter Fuller Mental Health Center, 85 E Newton St M-1013

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-32418

Identifier Type: -

Identifier Source: org_study_id