Iron Deficiency Anemia TreatmentNCT05153278
IV Iron Versus Standard Treatment for Iron Deficiency Anemia in the Emergency Department
An observational study of Iron Deficiency Anemia Treatment and Iron-deficiency, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Iron Deficiency Anemia Treatment, Iron-deficiency, Iron Deficiency Anemia Due to Blood Loss
- What is being tested?
- Packed red blood cells and Intravenous drug
- Type of treatment
- Injection or infusion
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2018to 26 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with iron deficiency anemia treated with intravenous iron or packed red blood cells
Who may be able to join
- 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
Who cannot join
- Patients with no records of follow up
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, 79905
About this study
Official title: Effectiveness and Impact of Intravenous Iron Versus Standard Treatment in Treating Iron Deficiency Anemia in the Emergency Department at University Medical Center
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.
Read the detailed 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.
- Conditions
- Iron Deficiency Anemia Treatment, Iron-deficiency, Iron Deficiency Anemia Due to Blood Loss, Iron Deficiency Anemia
- Being tested
- Packed red blood cells, Intravenous drug
- Keywords
- iron deficiency anemia
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Packed red blood cellsBiological
Also called PRBC
Standard treatment for iron deficiency anemia (control)
Intravenous drugDrug
Also called Intravenous iron
Experimental treatment for iron deficiency treatment
| Study group | Role | What they receive |
|---|---|---|
| Control group | Patients that received standard treatment (packed red blood cells) for iron deficiency anemia Receives: Biological: Packed red blood cells | |
| Experimental group | Patients that received intravenous iron instead of standard treatment (packed red blood cells) for iron deficiency anemia Receives: Drug: Intravenous drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin
Change in serum hemoglobin over time
Measured: 180 days
Secondary outcomes (1)
Change in MCV (mean corpuscular volume)
Change in MCV over time
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start26 Oct 2018
- Primary completion26 Aug 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anemia TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Patek, MD, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Gregory Patek, MD, Principal investigator, Texas Tech University Health Sciences Center, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153278
- Sponsor's protocol ID
- E18152
- Status last verified
- Mar 2022
- First submitted
- 29 Nov 2021
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Impact of Intravenous Iron Versus Standard Treatment in Treating Iron Deficiency Anemia in the Emergency Department at University Medical Center
- ClinicalTrials.gov ID
- NCT05153278
- Acronym / sponsor ID
- E18152
- Conditions
- Iron Deficiency Anemia Treatment, Iron-deficiency, Iron Deficiency Anemia Due to Blood Loss, Iron Deficiency Anemia
- Keywords
- iron deficiency anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 26 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Biological: Packed red blood cellsPatients that received standard treatment (packed red blood cells) for iron deficiency anemia |
| Experimental group | – | Drug: Intravenous drugPatients that received intravenous iron instead of standard treatment (packed red blood cells) for iron deficiency anemia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with iron deficiency anemia treated with intravenous iron or packed red blood cells
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with no records of follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Packed red blood cellsAlso: PRBCStandard treatment for iron deficiency anemia (control) | Biological | Control group |
| Intravenous drugAlso: Intravenous ironExperimental treatment for iron deficiency treatment | Drug | Experimental group |
Primary outcome
Change in hemoglobin
Time frame: 180 days
Change in serum hemoglobin over time
1 secondary outcome
Change in MCV (mean corpuscular volume)
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Patek, MD principal investigator
Texas Tech University Health Sciences Center, El Paso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia Treatment and Iron-deficiency, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.