IRB Granulocyte Project

A. APPLICATION FORM

 

The application form must be filled out completely so committee members may have a clear understanding of the nature and human subject implications of the research proposal.  A summary paragraph for each section is sufficient.  A statement referring to the attached materials is not sufficient and will not be accepted.  Applications submitted with incomplete forms will be returned without consideration of the proposal.

 

1. TITLE

 

Comparison of Immature Granulocyte Count and Elevated Versus Normal c-Reactive Protein in Patients with an Infectious Process.

 

2. DESCRIPTION OF STUDY

 

This study will be done using retrospective patient data stored in Primary Children’s Medical Center database and Sysmex back up files. Analysis of CRP, immature granulocyte count and microbiology results will take place. Patient identifiers will not be needed or used in this study.

 

3. DURATION OF THE STUDY

 

The duration of this study will be from October 2005 to March 2006.

 

4. MULTICENTER STUDY

 

Yes, this study will be conducted by Weber State Clinical Laboratory Science department with data being received and reviewed from Primary Children’s Medical Center Clinical Laboratory.  No patient identifiers will leave Primary Children’s Medical Center Laboratory. 

 

5. NUMBER OF SUBJECTS

 

Data will be collected from a minimum of 120 patient histories at Primary Children’s Medical Center.

 

6. HEALTH STATUS OF THE SUBJECT

 

Health status is assumed compromised based on the fact that the patient came to Primary Children’s Medical Center for medical attention.

 

7. SUBJECT GROUPS EXCLUDED

 

Only patients having a CRP and CBC drawn at the same time upon admit will be used in this study.

 

8. AGES OF SUBJECTS

 

Subjects will be between the ages of 0 days to 18 years old. The primary age group of patients treated at Primary Children’s Medical Center.

 

9. DESIGN OF THE STUDY

 

For our patient sample we purpose using new ER admits that have a CBC and CRP performed.  They will then be divided into the specified subsets.  A minimum of 30 patients will be in each subset.

 

10. RISKS TO SUBJECTS

 

There is no risk to patients.  Data will be collected on patients whose results have previously been released to the physician.  Therefore no patient interaction is necessary.

 

ANY MODERATE OR HIGH RISK STUDY MUST GO THROUGH A SEPARATE REVIEW PROCEDURE WHICH INCLUDES THE APPROPRIATE ADMINISTRATIVE OFFICER AND THE UNIVERSITY ATTORNEY.

 

11. BENEFITS TO SUBJECTS AND OTHERS

 

This study will lead to the use of the immature granulocyte count as another parameter used by physicians to monitor patients.  There will be no additional cost to the patient or hospital as the parameter is already included as a part of every CBC run on the Sysmex XE-2100.

 

12. COST TO BE BORNE BY SUBJECTS

 

There will be no cost to subjects.

 

13. IS CONFIDENTIALITY ASSURED

 

Patient name and other identifiers will be removed from the collected data before being analyzed. Each patient will be assigned a new identifying number for the study. A master log, referencing patient identifiers with new study identifiers, will be kept at Primary Children’s Medical Center in a locked drawer and will be destroyed upon conclusion of the study.

 

14. CONTRACT OR GRANT NUMBER

 

An application for grant approval to Weber State University Undergraduate Research Committee will be submitted on September 28, 2005. As of now we have no grant number.

 

15. NAME OF PRINCIPAL INVESTIGATOR AND DEPARTMENT

 

The investigator is Kara Hansen-Suchy from the Clinical Laboratory Science Department at Weber State University.

 

B. DESCRPTION OF THE STUDY

Abstract:

 

Primary Children’s Medical Center (PCMC) currently uses the Sysmex XE-2100 to perform complete blood counts (CBC).   Our study is retrospective and data will be collected on patients that had a CBC and CRP ordered at the same time.  Those results will be categorized into four subgroups; 1) elevated CRP and IG values 2) normal CRP and IG values 3) elevated CRP, but normal IG values and 4) normal CRP but elevated IG values.  This data will be analyzed to find specificity and sensitivity for CRP levels and the specified CBC parameters for patients that have positive microbiology cultures vs. those patients that have negative microbiology cultures.

The objective of this project is to compare the relationship between the IG count and elevated versus normal CRP’s in patients with an infectious process.

 

Detail Project Description:

Primary Children’s Medical Center (PCMC) currently uses the Sysmex XE-2100 to perform complete blood counts (CBC).  The Sysmex XE-2100 is a laboratory instrument that measures the cellular elements that comprise human blood.  The instrument automatically measures the presence of a particular line of white blood cells that are known to respond to various bacterial infections. This is the granulocytic white blood cell line. In a new software upgrade recently made available by Sysmex, an experimental parameter called, an Immature Granulocyte Count (IG) has been included. The IG categorizes and enumerates those granulocytes that are not yet fully mature and functional. Through our clinical laboratory curriculum we understand that the immature granulocytes are often increased in response to a bacterial infection and inflammation. This parameter is currently not being reported or utilized by PCMC.

Currently physicians at PCMC use the absolute neutrophil count (ANC), a component of the CBC, as an indicator of a patient having and infectious process. The ANC is also typically increased in response to an infectious or inflammatory process, but it is a labor intensive parameter, manually calculated by performing a microscopic differential.  In this study we will investigate and compare the IG parameter to the manual microscopic ANC parameter for it’s usefulness in predicting an infectious process.

The C-Reactive Protein (CRP) is another laboratory test known to be increased in infections and inflammation, and is often used as an indicator of a patient’s health status. Often a CBC and a CRP are ordered at the same time on children being cared for at PCMC. Our study proposes to investigate the relationship of CRP values to IG levels and if there is a correlation to an infectious process.

            Our study is retrospective with data being collected on patients that have had a CBC and CRP ordered at the same time.  The IG parameter from the CBC and CRP results will be categorized into four subgroups; 1) elevated CRP and IG values 2) normal CRP and IG values 3) elevated CRP, but normal IG values and 4) normal CRP but elevated IG values. We will then look at the data from other laboratory microbiology results to determine if there is a relationship of one or more of these subgroups to an infectious process. On these same patients a previously well made and stained blood smear will be pulled from the stored slide file for analysis by manual microscopy.  The manual microscopy results will be compared to the automated differential to determine the relationship between the manual ANC and the automated IG.

            The objective of this project is to compare the relationship between the IG count and elevated versus normal CRP’s in patients with an infectious process.  This could possibly culminate in the use of the IG parameter as an additional indicator to help the physician identify possible at risk patients for infections. Since the IG is already a feature on the Sysmex analyzer there would be no additional cost to the lab to utilize and report this available parameter. It would also be available with a more rapid turn around time than the CRP.

            Data and slides will be collected from PCMC with the expressed permission of the Medical Director Theodore Pyscher and laboratory Supervisor John Neville, using the facilities computer database, the Sysmex backup files and stored slide file. The analysis of the data and slides will be performed at WSU in the Hematology laboratory. No patient identifiers will leave PCMC.  The data and slides will be reassigned a unique identifier for subsequent tracking purposes.  The WSU faculty mentor will be consulted regularly. 

            The three students involved in this study have completed their Associate of Applied Science degree in Clinical Laboratory Sciences at Weber State University and are current students in the Bachelors of Science program participating in undergraduate research studies.  One of the three students (Diana Cotner) works for PCMC and will be the primary person collecting the data and slides for subsequent analysis

            The results of this study will be presented at the Utah Society for Clinical Laboratory Science (USCLS) Spring Seminar in April 2006 and at the Weber State University Undergraduate Research Symposium in March 2006. An application will be made to the Office of Undergraduate Research to present this project’s results at the National Conference of Undergraduate Research. Publication in a national professional journal will also be sought.

 

 

Dependent___________________________________________X____Independent

(Student helping faculty do research)               (Student doing own research)

 

 

Project method and Timeline:

Students involved in this project have completed IRB training and have submitted IRB applications to both WSU, and University of Utah (a requirement for research done at PCMC) as of 9/30/2005.  Absolutely no patient names or identifiers will be reported in this study. 

            For our patient sample, we propose using new emergency room admits that have a CBC and CRP performed.  They will then be divided into the specified subsets.  A minimum of 30 patients will be in each subset.

            All collected data will be analyzed to find specificity and sensitivity for CRP levels and the specified CBC parameters for patients that have positive microbiology cultures vs. those patients that have negative microbiology cultures .Data collection and analysis will begin in October 2005 and be completed by March, 2006.

 

References:

 

1. Briggs C., et al.: Performance Evaluation of the Sysmex XE-2100TM, Automated Haematology

            Analyser. Sysmex Journal International, Vol. 9, No. 2, 1999.

2. Nigro K., et al.: Performance of an Automated Immature Granulocyte Count as a Predictor

            of Neonatal Sepsis. American Society for Clinical Pathology 2005; 123: 618-624.

3. Brigg C., et al.: Evaluation of Immature Granulocyte count by the XE-IG master: upgraded

            software for the XE-2100 automated hematology analyzer. Laboratory Hematology;

Official Publication of the International Society for Laboratory Hematology, Vol. 9 (3),

2003: 117-124.

4. Husain T., et al.: C-Reactive Protein and Erythrocyte Sedimentation Rate in Orthopaedics.

            UPOJ, Vol. 15, 2002: 13-16.

 

 

Project budget:

 

  • Microscope 50X oil immersion objectives for performing manual differentials (times 3) @ $440.67 each:  $1322.01
  • Electronic Differential Tally counters for performing manual differentials (times 2) @ $557.95 each: $1115.90
  • Miscellaneous supplies, i.e., microscope oil, paper, pens, printer ink, presentation supplies, computer disks: $350.00
  • Travel reimbursement at $.30 per mile for one trip per week a total of 8 weeks at 35.3 one way: $ 169.44
  • Total budget: $2957.35 

 

C. INFORMED CONSENT

 

No informed consent is needed because we will not be interacting with patients or their treatment.  This study only involves the use of data collected on previously treated patients.

 

 

D. EXPERIMENTAL SUBJECT’S BILL OF RIGHTS

 

No Bill of Right’s is needed because we will not be interacting with patients or their treatment.  This study only involves the use of data collected on previously treated patients.


Weber State UniversityOgden, Utah 84408

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