Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05153278 |
| Other study ID # |
E18152 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 26, 2018 |
| Est. completion date |
August 26, 2020 |
Study information
| Verified date |
March 2022 |
| Source |
Texas Tech University Health Sciences Center, El Paso |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The investigators will retrospectively collect data of patients infused at UMC's emergency
department (ED) with long acting irons (ferric carboxymaltose, iron dextran, iron sucrose,
etc.), in addition, patients infused with blood products, with intent to treat iron
deficiency anemia (IDA). Patient records reviewed will be from patients who were infused at
UMC ED from January 2013 to June 2018. Primary aim of analysis will be to investigate
superiority between interventions implemented for treating IDA. In addition, the
investigators will utilize data to characterize patients who used ED services as an avenue to
receive treatment for IDA. Further, the investigators will conduct cost analysis between
different IDA directed treatments administered in the ED at UMC.
Description:
Background:
Iron deficiency anemia (IDA) is a condition that impacts approximately 2-billion people
globally, and impacts individuals from all socioeconomic backgrounds, making it one of the
most common nutritional disorders in the world. In any population, women and children are the
groups that are more susceptible to suffering from IDA [3]. IDA has broad influences on the
health of an individual, ranging from cognitive decline to motor deficits. When coupled with
pregnancy, IDA has been shown to be associated with low birth weight and carries an increased
risk of maternal and perinatal mortality. In addition to women and children, the prevalence
of IDA has been found to increase with age, and with chronic disease. The approach to
treating IDA regularly begins with oral iron supplementation. However, due to increased
gastrointestinal side effects or excessive losses of iron, intravenous iron has been shown to
be better tolerated. Further, intravenous iron is another attractable iron replacement
strategy in IDA when the need for rapid delivery is required, such as in pregnancy or
following traumas. When compared to blood products, intravenous iron is an attractive option
due to its ready availability. With a growing and aging population it is important that major
health problems such as IDA be investigated further in order to identify sustainable
therapeutic strategies.
Benefits of Study:
This retrospective study will provide the investigators with valuable knowledge on which
treatment for IDA may be most effective in treating our El Paso population of patients
suffering from IDA (Primary Aim). This study will also allow the investigators to identify
which IDA treatment is most cost effective (Secondary Aim A), and which population of the
community would benefit the most from an outpatient infusion service (Secondary Aim B).
Chart Inclusion Criteria:
All patients receiving one IDA intervention in the UMC ED who had at least one complete blood
count or hemoglobin after discharge from the emergency department or hospital.
Exclusion Criteria:
Patients with no records of follow up.
Identification:
Collection of Patient Records and Data: Patient records reviewed will be from patients who
were infused at UMC ED from January 2013 to June 2018. The age group of patients will be
those greater than 18 years of age. The investigators will include all patients presenting to
or treated at UMC ED during this five and one-half year period. Patient information such as
unique identifiers (e.g. medical record number, hospital account number) will be used to
navigate patient records for approved research personnel only. No procedures will be
performed as part of this study. All data will be collected as a retrospective chart review.
The investigators will access patient data through both UMC and Texas Tech electronic medical
records as patients who received an intervention may have received follow up in a Texas Tech
clinic rather than the UMC emergency department. The only risk of this study is the potential
for loss of confidentiality. Research personnel will take extra measures to reduce this risk.
The researchers will not publish any data that can be used to identify the patient, such as
but not limited to personal or unique identifiers, medical record numbers, hospital account
numbers or date of birth.
Experiment group:
Patient charts will be identified through digital records of UMC pharmacy and UMC blood bank.
Patients included, will be those listed to have IDA by set criteria [Listed below], and who
were treated with at least one IDA intervention other than blood product transfusion. Control
group will be formed using patients who received at least one IDA intervention using blood
product transfusion only. The investigators will attempt to match charts by age, condition
leading to IDA, and gender in final analysis.
Set criteria:
Patient charts will be identified if they were the recipient of listed blood and bloodless
transfusion products for treatment of IDA.
