NCT05153278

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

1.8 years

First QC Date

November 29, 2021

Last Update Submit

March 8, 2022

Conditions

Keywords

iron deficiency anemia

Outcome Measures

Primary Outcomes (1)

  • Change in hemoglobin

    Change in serum hemoglobin over time

    180 days

Secondary Outcomes (1)

  • Change in MCV (mean corpuscular volume)

    180 days

Study Arms (2)

Control group

Patients that received standard treatment (packed red blood cells) for iron deficiency anemia

Biological: Packed red blood cells

Experimental group

Patients that received intravenous iron instead of standard treatment (packed red blood cells) for iron deficiency anemia

Drug: Intravenous drug

Interventions

Standard treatment for iron deficiency anemia (control)

Also known as: PRBC
Control group

Experimental treatment for iron deficiency treatment

Also known as: Intravenous iron
Experimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with iron deficiency anemia treated with intravenous iron or packed red blood cells

You may qualify if:

  • 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

You may not qualify if:

  • Patients with no records of follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University Health Sciences Center El Paso

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Infusion Pumps

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Equipment and SuppliesArtificial OrgansSurgical Equipment

Study Officials

  • Gregory Patek, MD

    Texas Tech University Health Sciences Center, El Paso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 10, 2021

Study Start

October 26, 2018

Primary Completion

August 26, 2020

Study Completion

August 26, 2020

Last Updated

March 24, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations