Anemia, Iron DeficiencyAIDANCT04071067
Anemia of Inflammation and Deficiency Anemia
An observational study of Anemia, Iron Deficiency and Anemia of Chronic Disease, run by Iuliu Hatieganu University of Medicine and Pharmacy at 2 sites in Romania.
Trial summary
Critical patients which requiring admission to intensive care (IT) are a special group of patients. In these patients the prevalence of anemia reported in studies is 75%. This prevalence is similar to that in the retrospective observational study conducted in our intensive care unit(ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Iron Deficiency, Anemia of Chronic Disease
- How many people
- 1,000 participants
- Where
- 2 sitesRomania
- Study dates
- 1 Jan 2020to 1 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to ICU during the study period which do not meet any exclusion criteria
Who may be able to join
- Patients admitted to ICU
- ICU stay >48hours
Who cannot join
- Refusal to participate in the study
- Allergy to iron products
- Anemia requiring massive transfusion in the last 7 days
- Treatment of iron products in the last 7 days
- Chronic renal failure with GFR <30mL / min or on dialysis
- Metabolism of iron
Show all 11Show fewer
- Pregnant or lactation patients
- Rheumatic diseases
- Inflammatory bowel diseases
- Hematological pathologies
- Impossibility of performing laboratory tests within 72 hours of admission
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
Emergency Clinical County Hospital Cluj Napoca
Cluj-Napoca, Cluj
Robert Szabo, Resident MD, 0040755628255, robsz11@yahoo.com
Cristina Petrisor, MD PhD
Municipal Clinical Hospital Cluj
Cluj-Napoca, Cluj
Robert Szabo, Resident MD, 0040755628255, robsz11@yahoo.com
Constantin Bodolea, MD PhD
About this study
Official title: Anemia of Inflammation and Deficiency Anemia in Critically Ill Patients; Biological Markers
Critical patients which requiring admission to intensive care (IT) are a special group of patients. In these patients the prevalence of anemia reported in studies is 75%. This prevalence is similar to that in the retrospective observational study conducted in our intensive care unit(ICU). Of the 783 patients included in the study, 551 (73.37%) had anemia on admission. Frequently anemia is present on discharge from ICU or hospital and may persist for an average of 11 weeks. Some studies have reported the presence of anemia as far as 6 months after discharge. It is widely accepted that anemia has a negative impact on rehabilitation and quality of life, but the treatment can not be exclusively based on blood products due to the risks associated with transfusion. Alternative treatments such as injectable iron or erythropoietin should be considered.
The Transfusion Management Initiative Group recently issued recommendations on perioperative anemia. Similar recommendations for ICU have not yet been developed in Romania. The current study has two main purposes. The first to adopt the perioperative anemia diagnostic algorithm and adapt it to anemic patients on ICU; the second to identify patients with mixed anemia (inflammatory and iron deficient anemia) who can benefit from treatment with iron.
- Conditions
- Anemia, Iron Deficiency, Anemia of Chronic Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Clinical County Hospital Group | Not described | |
| Municipal Clinical Hospital Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin levels during ICU stay
Measured: 21 days: day 0=point 1; day 7=point 2; day 14=point 3; day 21 =point 4;
Number of transfusions during ICU stay
Measured: Up to 3 months of hospital stay
Secondary outcomes (4)
Days spent on ICU
Measured: Up to 3 months of hospital stay
Days spent in hospital
Measured: Up to 3 months
Change in hemoglobin level during hospital stay
Measured: Up to 3 months: week 3=point 1; week 6=point 2; week 9=point 3; week 12=point4
Number of hours of mechanical ventilation during hospital stay
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron DeficiencyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Constantin Bodolea, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Constantin Bodolea, Md PhD, Principal investigator, 2nd Anesthesia Department of University of Medicine and Pharmacy Cluj Napoca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071067
- Sponsor's protocol ID
- 89/8.04.2019
- Acronym
- AIDA
- Status last verified
- Aug 2019
- First submitted
- 1 Jul 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Filipescu D, Banateanu R, Beuran M, Burcos T, Corneci D, Cristian D, Diculescu M, Dobrota A, Droc G, Isacoff D, Gosa D, Grintescu I, Lupu A, Mirea L, Posea C, Stanca O, Stefan M, Tomescu D, Tudor C, Ungureanu D, Mircescu G. Perioperative Patient Blood Management Programme. Multidisciplinary recommendations from the Patient Blood Management Initiative Group. Rom J Anaesth Intensive Care. 2017 Oct;24(2):139-157. doi: 10.21454/rjaic.7518.242.fil.
PubMed 29090267
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anemia of Inflammation and Deficiency Anemia in Critically Ill Patients; Biological Markers
- ClinicalTrials.gov ID
- NCT04071067
- Acronym / sponsor ID
- AIDA / 89/8.04.2019
- Conditions
- Anemia, Iron Deficiency, Anemia of Chronic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 28 Aug 2019 (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.
Critical patients which requiring admission to intensive care (IT) are a special group of patients. In these patients the prevalence of anemia reported in studies is 75%. This prevalence is similar to that in the retrospective observational study conducted in our intensive care unit(ICU). Of the 783 patients included in the study, 551 (73.37%) had anemia on admission. Frequently anemia is present on discharge from ICU or hospital and may persist for an average of 11 weeks. Some studies have reported the presence of anemia as far as 6 months after discharge. It is widely accepted that anemia has a negative impact on rehabilitation and quality of life, but the treatment can not be exclusively based on blood products due to the risks associated with transfusion. Alternative treatments such as injectable iron or erythropoietin should be considered.
The Transfusion Management Initiative Group recently issued recommendations on perioperative anemia. Similar recommendations for ICU have not yet been developed in Romania. The current study has two main purposes. The first to adopt the perioperative anemia diagnostic algorithm and adapt it to anemic patients on ICU; the second to identify patients with mixed anemia (inflammatory and iron deficient anemia) who can benefit from treatment with iron.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency Clinical County Hospital Group | – | – |
| Municipal Clinical Hospital Group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to ICU during the study period which do not meet any exclusion criteria
Key inclusion criteria (2 listed)
- Patients admitted to ICU
- ICU stay >48hours
Key exclusion criteria (11 listed)
- Refusal to participate in the study
- Allergy to iron products
- Anemia requiring massive transfusion in the last 7 days
- Treatment of iron products in the last 7 days
- Chronic renal failure with GFR <30mL / min or on dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in hemoglobin levels during ICU stay
Time frame: 21 days: day 0=point 1; day 7=point 2; day 14=point 3; day 21 =point 4;
Number of transfusions during ICU stay
Time frame: Up to 3 months of hospital stay
4 secondary outcomes
Days spent on ICU
Time frame: Up to 3 months of hospital stay
Days spent in hospital
Time frame: Up to 3 months
Change in hemoglobin level during hospital stay
Time frame: Up to 3 months: week 3=point 1; week 6=point 2; week 9=point 3; week 12=point4
Number of hours of mechanical ventilation during hospital stay
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background: PubMed 29090267Filipescu D, Banateanu R, Beuran M, Burcos T, Corneci D, Cristian D, Diculescu M, Dobrota A, Droc G, Isacoff D, Gosa D, Grintescu I, Lupu A, Mirea L, Posea C, Stanca O, Stefan M, Tomescu D, Tudor C, Ungureanu D, Mircescu G. Perioperative Patient Blood Management Programme. Multidisciplinary recommendations from the Patient Blood Management Initiative Group. Rom J Anaesth Intensive Care. 2017 Oct;24(2):139-157. doi: 10.21454/rjaic.7518.242.fil.
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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.
Constantin Bodolea, Md PhD principal investigator
2nd Anesthesia Department of University of Medicine and Pharmacy Cluj Napoca
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, Iron Deficiency and Anemia of Chronic Disease, run by Iuliu Hatieganu University of Medicine and Pharmacy at 2 sites in Romania.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Szabo, Resident MD (0040755628255, robsz11@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin levels during ICU stay (time frame: 21 days: day 0=point 1; day 7=point 2; day 14=point 3; day 21 =point 4;). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04071067, which also lists 1 linked publication.
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 28 Aug 2019.