Iron Deficiency AnemiaNCT05673161
Retrospective Evaluation of the Effect of Iron (Fe) Infusion on Complications in Anemic Patients Undergoing Thoracotomy
An observational study of Iron Deficiency Anemia and Iron Deficiency Anemia Treatment, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
In patients who underwent thoracotomy due to lung malignancy; It is desired to investigate whether there is a difference in terms of postoperative results between those with and without anemia, and those with iron deficiency anemia (IDA) who underwent intravenous iron replacement and those who did not, according to… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Iron Deficiency Anemia, Iron Deficiency Anemia Treatment
- What is being tested?
- iron
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 15 Dec 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergone thoracotomy
Who may be able to join
- thoracotomy patients
Who cannot join
- emergency cases
Trial locations and contacts
1 site in 1 country.
About this study
In patients who underwent thoracotomy due to lung malignancy; It is desired to investigate whether there is a difference in terms of postoperative results between those with and without anemia, and those with iron deficiency anemia (IDA) who underwent intravenous iron replacement and those who did not, according to the hemoglobin value in their preoperative examinations.
- Being tested
- iron
- 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.
ironOther
iron treatment
| Study group | Role | What they receive |
|---|---|---|
| anemia, treatment | anemic patients who had iron therapy Receives: Other: iron | |
| anemia, no treatment | anemic patients who had no therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who had postoperatiive complication
postoperative complication
Measured: 3 days
number of patients who received blood products
use of blood product
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start15 Nov 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CIGDEM YILDIRIM GUCLU, Ankara University
- Investigators
- CIGDEM YILDIRIM GUCLU, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673161
- Sponsor's protocol ID
- 2022/613
- Status last verified
- Jan 2023
- First submitted
- 21 Dec 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After publishing the manuscript
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of the Effect of Iron (Fe) Infusion on Complications in Anemic Patients Undergoing Thoracotomy
- ClinicalTrials.gov ID
- NCT05673161
- Acronym / sponsor ID
- 2022/613
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 6 Jan 2023 (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.
In patients who underwent thoracotomy due to lung malignancy; It is desired to investigate whether there is a difference in terms of postoperative results between those with and without anemia, and those with iron deficiency anemia (IDA) who underwent intravenous iron replacement and those who did not, according to the hemoglobin value in their preoperative examinations.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anemia, treatment | – | Other: ironanemic patients who had iron therapy |
| anemia, no treatment | – | –anemic patients who had no therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergone thoracotomy
Key inclusion criteria (1 listed)
- thoracotomy patients
Key exclusion criteria (1 listed)
- emergency cases
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 |
|---|---|---|
| ironiron treatment | Other | anemia, treatment |
Primary outcome
number of patients who had postoperatiive complication
Time frame: 3 days
postoperative complication
number of patients who received blood products
Time frame: 3 days
use of blood product
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 6 Jan 2023.
- Individual participant dataSharing planned: No. After publishing the manuscript
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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.
CIGDEM YILDIRIM GUCLU principal investigator
Ankara University
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 and Iron Deficiency Anemia Treatment, run by Ankara University at 1 site in Turkey (Türkiye).
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 6 Jan 2023. 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 Turkey (Türkiye). 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?
number of patients who had postoperatiive complication (time frame: 3 days). 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?
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 6 Jan 2023.