GastroIntestinal BleedingPhase 4FIERCENCT05060731
Iron Supplementation in Upper Non-variceal Gastrointestinal Bleeding
A Phase 4 study testing Oral iron supplementation and Intravenous iron supplementation in people with GastroIntestinal Bleeding and Anemia, run by University of Pecs at 1 site in Hungary.
Trial summary
Anemia is a frequent complication of gastrointestinal bleeding, affecting 61% of the patients. Currently, anemia caused by gastrointestinal bleeding can be treated with iron supplementation. However, the dose and route of the administration are still a question. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- GastroIntestinal Bleeding, Anemia
- What is being tested?
- Oral iron supplementation and Intravenous iron supplementation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2025to 1 Feb 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age ≥ 65 years;
- endoscopically proven acute nonvariceal GIB source;
- 48 hours after the endoscopic diagnosis and/or treatment;
- hemodynamically stable;
- the discharge of the patient is planned;
- hemoglobin level <10 g/dl on the day of randomisation;
- 24 hours after the last transfusion and no need for further transfusion;
- signed informed consent.
Who cannot join
- known hypersensitivity to iron products (mild side effects excluded);
- previous diagnosis of iron overload [e.g., transferrin receptor saturation (TSAT) >50%, ferritin> 160 for women ng/ml, ferritin >270 ng/ml for men) or disorders of iron utilisation;
- pregnancy or breast feeding;
- diagnosis of iron malabsorption (at discretion of the attending clinician; e.g., severe inflammatory bowel disease, active celiac disease);
- chronic end stage diseases (chronic heart failure-New York Heart Association Classification class 4, chronic kidney disease (eGFR <30 mL/min/1.73 m2) with or without dialysis, liver cirrhosis with Child Pugh C score, chronic kidney disease with dialysis, chronic obstructive pulmonary disease stage 4, chronic inflammatory disease, malignancies, AIDS);
- active malignancies;
Show all 14Show fewer
- liver cirrhosis with known varices at high risk of bleeding - endoscopic features of high risk of variceal bleeding or liver stiffness measured by transient elastography >20 kiloPascal and platelet count <150 × 10^9 cells/L;
- gastrointestinal tract malignancies with high risk of gastrointestinal bleeding;
- high risk of poor compliance or no fixed abode;
- myelo- or lymphoproliferative diseases;
- anemia not attributable to iron deficiency (sideroblastic anaemia, aplastic anaemia, haemolytic anaemia, thalassaemia, B12 vitamin or folic acid deficiency or combination of these with IDA);
- primary coagulation disorders (e.g. Glanzmann thrombasthenia, Von Willebrand disease, Haemophylia A, Haemophylia B);
- the patient will be transferred to another institute after discharge (e.g. hospital, senior care center);
- Eastern Cooperative Oncology Group (ECOG) Performance Status >2.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site
Institute for Translational Medicine, University of Pécs
Pécs, 7624
About this study
Official title: Intravenous Ferric Carboxymaltose Versus Oral Ferrous Sulfate Replacement in Anaemia Due to Acute Nonvariceal Gastrointestinal Bleeding (FIERCE): Protocol of a Multicentre Randomised Controlled Trial
Anemia is a frequent complication of gastrointestinal bleeding, affecting 61% of the patients. Currently, anemia caused by gastrointestinal bleeding can be treated with iron supplementation. However, the dose and route of the administration are still a question. The FIERCE clinical trial aims to compare the effect of intravenous iron supplementation and oral iron replacement on mortality, unplanned emergency visits, and hospital readmissions in multimorbid patients with acute nonvariceal gastrointestinal bleeding.
Read the detailed description
In gastrointestinal bleeding (GIB) iron deficiency anemia (IDA) is a common complication, affecting more than 60% of the patients. There are two pillars of the treatment of acute GIB. First, the bleeding point needs identification and endoscopic treatment. Second, the resulting hypovolemia and anemia require fluid resuscitation, transfusion, and replacement of the lost iron. There are two simple ways to manage IDA after acute GIB. Patients either have intravenous (IV) iron infusions one to six times as part of their hospital treatment or receive three months of oral iron supplementation. There is a gap in current guidelines on which approach clinicians should choose.
Here the investigators plan a multicentric, two-arm, randomized controlled trial, to compare the efficacy of oral and intravenous iron supplementation in multimorbid patients with acute nonvariceal gastrointestinal bleeding. Patients will be randomly allocated in a 1:1 ratio to two groups. Group A will receive one dose of 1000 mg of IV ferric carboxymaltose on the day of randomization, while iron supplementation for group B will be performed with one ferrous sulfate tablet every day (ca. 200-300 mg) for three months. The primary outcome will be the composite outcome of all-cause mortality, unplanned emergency visit, and unplanned hospital readmission within six months after enrollment.
In the first phase, the investigators plan to recruit 15 patients on each arm to assess the proportion of the primary outcome in the two groups. In the second phase, a sample size calculation for the primary outcome will be performed based on the results of the first phase.
- Conditions
- GastroIntestinal Bleeding, Anemia
- Being tested
- Oral iron supplementation, Intravenous iron supplementation
- Keywords
- non-variceal upper gastrointersinal bleeding, iron supplementation, intravenous iron
- Medical subject headings
- Gastrointestinal Hemorrhage, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral iron supplementationDrug
Ca. 200-300 mg of ferrous sulfate will be administered orally every day for 3 months.
Intravenous iron supplementationDrug
One dose of intravenous 1000 mg ferric carboxymaltose will be administered on the day of randomization.
| Study group | Role | What they receive |
|---|---|---|
| Oral iron supplementation | Active comparator | Patients randomized to receive oral ferrous sulfate, ca. 200-300 mg every day for 3 months. Receives: Drug: Oral iron supplementation |
| Intravenous iron supplementation | Active comparator | Patients randomized to receive one dose of 1000 mg intravenous ferric carboxymaltose. Receives: Drug: Intravenous iron supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome
The composite endpoint includes all-cause mortality, unplanned emergency visit (general practitioner or emergency outpatient clinic), and unplanned hospital admission for any reason. The investigators will calculate the proportion of the outcome in each arm.
Measured: 3 months
Secondary outcomes (25)
All-cause mortality
Death from any cause. The proportion of the outcome will be calculated in each arm and compared between the arms. The investigators will compare subgroups of patients based on the cause of mortality.
Measured: 1, and 3 months
Unplanned emergency visits
Emergency visit from any cause. The proportion of the outcome will be calculated in each arm and compared between the arms. The investigators will compare subgroups of patients based on the cause of unplanned emergency visits.
Measured: 1, and 3 months
Unplanned hospital admission
Hospital admission from any cause. The proportion of the outcome will be calculated in each arm and compared between the arms. The investigators will compare subgroups of patients based on the cause of unplanned admission.
Measured: 1, and 3 months
Quality of life using the 36-Item Short-Form Health Survey
Changes in quality of life measured with the 36-Item Short-Form Health Survey (SF-36) questionnaire compared to baseline.
Measured: 1, and 3 months +/- 7 days
Quality of life using the EuroQol five-dimensions - 5 levels questionnare
Changes in quality of life measured with the EuroQol five-dimensions - 5 levels (EQ-5D-5L) questionnaire compared to baseline.
Measured: 1, and 3 months +/- 7 days
Gait speed
Changes in gait speed compared to baseline. Gait speed will be evaluated on a 4-meter flat walking path.
Measured: 1, and 3 months +/- 7 days
Six-Minute Walk Test (6MWT)
Changes in Six-Minute Walk Test (6MWT) compared to baseline.
Measured: 1, and 3 months +/- 7 days
Handgrip strength
Changes in handgrip strength compared to baseline.
Measured: 1, and 3 months +/- 7 days
Normalization of the haemoglobin level
The percentage of participants with Hb levels of ≥12 g/dL in women and ≥13 g/d, compared to baseline.
Measured: 1, and 3 months +/- 7 days
Change in Hb level
Absolute change from baseline to follow-up in Hb level.
Measured: 1, and 3 months +/- 7 days
Change in haematocrit
Absolute change from baseline to follow-up in haematocrit.
Measured: 1, and 3 months +/- 7 days
Change in serum iron level
Absolute change from baseline to follow-up in serum iron level.
Measured: 1, and 3 months +/- 7 days
Change in serum transferrin level
Absolute change from baseline to follow-up in serum transferrin level.
Measured: 1, and 3 months +/- 7 days
Change in transferrin saturation
Absolute change from baseline to follow-up in transferrin saturation.
Measured: 1, and 3 months +/- 7 days
Change in soluble transferrin receptor concentration
Absolute change from baseline to follow-up in soluble transferrin receptor (sTfR) concentration.
Measured: 1, and 3 months +/- 7 days
Change in ferritin level
Absolute change from baseline to follow-up in ferritin level.
Measured: 1, and 3 months +/- 7 days
Change in the number of reticulocytes
Absolute change from baseline to follow-up in the number of reticulocytes.
Measured: 1, and 3 months +/- 7 days
Change in the number of erythrocytes
Absolute change from baseline to follow-up in the number of erythrocytes.
Measured: 1, and 3 months +/- 7 days
Change in the total iron-binding capacity
Absolute change from baseline to follow-up in the total iron-binding capacity (TIBC).
Measured: 1, and 3 months +/- 7 days
Change in erythropoietin level
Absolute change from baseline to follow-up in erythropoietin level.
Measured: 1, and 3 months +/- 7 days
Change in C-reactive protein level
Absolute change from baseline to follow-up in the C-reactive protein level.
Measured: 1, and 3 months +/- 7 days
Change in hepcidin level
Absolute change from baseline to follow-up in hepcidin level.
Measured: 1, and 3 months +/- 7 days
Change in phosphate level
Absolute change from baseline to follow-up in phosphate level.
Measured: 1, and 3 months +/- 7 days
Discontinuation of the treatment due to adverse events
The percentage of discontinuation in the two arms.
Measured: 1, and 3 months +/- 7 days
Cost-effectiveness
The incremental cost-effectiveness ratio (ICER): incremental costs divided by incremental effectiveness .
Measured: 1, and 3 months +/- 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for GastroIntestinal BleedingStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators plan to recruit 285 patients on each arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr Erőss Bálint, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060731
- Sponsor's protocol ID
- 46395-5/2021/EÜIG
- Acronym
- FIERCE
- Status last verified
- Oct 2024
- First submitted
- 17 Sep 2021
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McNutt MK, Bradford M, Drazen JM, Hanson B, Howard B, Jamieson KH, Kiermer V, Marcus E, Pope BK, Schekman R, Swaminathan S, Stang PJ, Verma IM. Transparency in authors' contributions and responsibilities to promote integrity in scientific publication. Proc Natl Acad Sci U S A. 2018 Mar 13;115(11):2557-2560. doi: 10.1073/pnas.1715374115. Epub 2018 Feb 27.
PubMed 29487213McLean E, Cogswell M, Egli I, Wojdyla D, de Benoist B. Worldwide prevalence of anaemia, WHO Vitamin and Mineral Nutrition Information System, 1993-2005. Public Health Nutr. 2009 Apr;12(4):444-54. doi: 10.1017/S1368980008002401. Epub 2008 May 23.
PubMed 18498676Ferrer-Barcelo L, Sanchis Artero L, Sempere Garcia-Arguelles J, Canelles Gamir P, P Gisbert J, Ferrer-Arranz LM, Monzo Gallego A, Plana Campos L, Huguet Malaves JM, Lujan Sanchis M, Ruiz Sanchez L, Barcelo Cerda S, Medina Chulia E. Randomised clinical trial: intravenous vs oral iron for the treatment of anaemia after acute gastrointestinal bleeding. Aliment Pharmacol Ther. 2019 Aug;50(3):258-268. doi: 10.1111/apt.15327. Epub 2019 Jun 14.
PubMed 31197861Bager P, Dahlerup JF. Randomised clinical trial: oral vs. intravenous iron after upper gastrointestinal haemorrhage--a placebo-controlled study. Aliment Pharmacol Ther. 2014 Jan;39(2):176-87. doi: 10.1111/apt.12556. Epub 2013 Nov 19.
PubMed 24251969Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.
PubMed 25700159Sultan P, Bampoe S, Shah R, Guo N, Estes J, Stave C, Goodnough LT, Halpern S, Butwick AJ. Oral vs intravenous iron therapy for postpartum anemia: a systematic review and meta-analysis. Am J Obstet Gynecol. 2019 Jul;221(1):19-29.e3. doi: 10.1016/j.ajog.2018.12.016. Epub 2018 Dec 19.
PubMed 30578747Cotter J, Baldaia C, Ferreira M, Macedo G, Pedroto I. Diagnosis and treatment of iron-deficiency anemia in gastrointestinal bleeding: A systematic review. World J Gastroenterol. 2020 Dec 7;26(45):7242-7257. doi: 10.3748/wjg.v26.i45.7242.
PubMed 33362380Teutsch B, Vancsa S, Farkas N, Szakacs Z, Vorhendi N, Boros E, Szabo I, Hagendorn R, Alizadeh H, Hegyi P, Eross B. Intravenous ferric carboxymaltose versus oral ferrous sulfate replacement in elderly patients after acute non-variceal gastrointestinal bleeding (FIERCE): protocol of a multicentre, open-label, randomised controlled trial. BMJ Open. 2023 Mar 14;13(3):e063554. doi: 10.1136/bmjopen-2022-063554.
PubMed 36918236
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Ferric Carboxymaltose Versus Oral Ferrous Sulfate Replacement in Anaemia Due to Acute Nonvariceal Gastrointestinal Bleeding (FIERCE): Protocol of a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05060731
- Acronym / sponsor ID
- FIERCE / 46395-5/2021/EÜIG
- Conditions
- GastroIntestinal Bleeding, Anemia
- Keywords
- non-variceal upper gastrointersinal bleeding, iron supplementation, intravenous iron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 29 Sep 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.
Anemia is a frequent complication of gastrointestinal bleeding, affecting 61% of the patients. Currently, anemia caused by gastrointestinal bleeding can be treated with iron supplementation. However, the dose and route of the administration are still a question. The FIERCE clinical trial aims to compare the effect of intravenous iron supplementation and oral iron replacement on mortality, unplanned emergency visits, and hospital readmissions in multimorbid patients with acute nonvariceal gastrointestinal bleeding.
Detailed description
In gastrointestinal bleeding (GIB) iron deficiency anemia (IDA) is a common complication, affecting more than 60% of the patients. There are two pillars of the treatment of acute GIB. First, the bleeding point needs identification and endoscopic treatment. Second, the resulting hypovolemia and anemia require fluid resuscitation, transfusion, and replacement of the lost iron. There are two simple ways to manage IDA after acute GIB. Patients either have intravenous (IV) iron infusions one to six times as part of their hospital treatment or receive three months of oral iron supplementation. There is a gap in current guidelines on which approach clinicians should choose.
Here the investigators plan a multicentric, two-arm, randomized controlled trial, to compare the efficacy of oral and intravenous iron supplementation in multimorbid patients with acute nonvariceal gastrointestinal bleeding. Patients will be randomly allocated in a 1:1 ratio to two groups. Group A will receive one dose of 1000 mg of IV ferric carboxymaltose on the day of randomization, while iron supplementation for group B will be performed with one ferrous sulfate tablet every day (ca. 200-300 mg) for three months. The primary outcome will be the composite outcome of all-cause mortality, unplanned emergency visit, and unplanned hospital readmission within six months after enrollment.
In the first phase, the investigators plan to recruit 15 patients on each arm to assess the proportion of the primary outcome in the two groups. In the second phase, a sample size calculation for the primary outcome will be performed based on the results of the first phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators plan to recruit 285 patients on each arm.
| Arm | Type | Receives |
|---|---|---|
| Oral iron supplementation | Active comparator | Drug: Oral iron supplementationPatients randomized to receive oral ferrous sulfate, ca. 200-300 mg every day for 3 months. |
| Intravenous iron supplementation | Active comparator | Drug: Intravenous iron supplementationPatients randomized to receive one dose of 1000 mg intravenous ferric carboxymaltose. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- age ≥ 65 years;
- endoscopically proven acute nonvariceal GIB source;
- 48 hours after the endoscopic diagnosis and/or treatment;
- hemodynamically stable;
- the discharge of the patient is planned;
Key exclusion criteria (14 listed)
- known hypersensitivity to iron products (mild side effects excluded);
- previous diagnosis of iron overload [e.g., transferrin receptor saturation (TSAT) >50%, ferritin> 160 for women ng/ml, ferritin >270 ng/ml for men) or disorders of iron utilisation;
- pregnancy or breast feeding;
- diagnosis of iron malabsorption (at discretion of the attending clinician; e.g., severe inflammatory bowel disease, active celiac disease);
- chronic end stage diseases (chronic heart failure-New York Heart Association Classification class 4, chronic kidney disease (eGFR <30 mL/min/1.73 m2) with or without dialysis, liver cirrhosis with Child Pugh C score, chronic kidney disease with dialysis, chronic obstructive pulmonary disease stage 4, chronic inflammatory disease, malignancies, AIDS);
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 |
|---|---|---|
| Oral iron supplementationCa. 200-300 mg of ferrous sulfate will be administered orally every day for 3 months. | Drug | Oral iron supplementation |
| Intravenous iron supplementationOne dose of intravenous 1000 mg ferric carboxymaltose will be administered on the day of randomization. | Drug | Intravenous iron supplementation |
Primary outcome
Composite outcome
Time frame: 3 months
The composite endpoint includes all-cause mortality, unplanned emergency visit (general practitioner or emergency outpatient clinic), and unplanned hospital admission for any reason. The investigators will calculate the proportion of the outcome in each arm.
25 secondary outcomes
All-cause mortality
Time frame: 1, and 3 months
Unplanned emergency visits
Time frame: 1, and 3 months
Unplanned hospital admission
Time frame: 1, and 3 months
Quality of life using the 36-Item Short-Form Health Survey
Time frame: 1, and 3 months +/- 7 days
Quality of life using the EuroQol five-dimensions - 5 levels questionnare
Time frame: 1, and 3 months +/- 7 days
Gait speed
Time frame: 1, and 3 months +/- 7 days
Six-Minute Walk Test (6MWT)
Time frame: 1, and 3 months +/- 7 days
Handgrip strength
Time frame: 1, and 3 months +/- 7 days
Normalization of the haemoglobin level
Time frame: 1, and 3 months +/- 7 days
Change in Hb level
Time frame: 1, and 3 months +/- 7 days
Change in haematocrit
Time frame: 1, and 3 months +/- 7 days
Change in serum iron level
Time frame: 1, and 3 months +/- 7 days
Change in serum transferrin level
Time frame: 1, and 3 months +/- 7 days
Change in transferrin saturation
Time frame: 1, and 3 months +/- 7 days
Change in soluble transferrin receptor concentration
Time frame: 1, and 3 months +/- 7 days
Change in ferritin level
Time frame: 1, and 3 months +/- 7 days
Change in the number of reticulocytes
Time frame: 1, and 3 months +/- 7 days
Change in the number of erythrocytes
Time frame: 1, and 3 months +/- 7 days
Change in the total iron-binding capacity
Time frame: 1, and 3 months +/- 7 days
Change in erythropoietin level
Time frame: 1, and 3 months +/- 7 days
Change in C-reactive protein level
Time frame: 1, and 3 months +/- 7 days
Change in hepcidin level
Time frame: 1, and 3 months +/- 7 days
Change in phosphate level
Time frame: 1, and 3 months +/- 7 days
Discontinuation of the treatment due to adverse events
Time frame: 1, and 3 months +/- 7 days
Cost-effectiveness
Time frame: 1, and 3 months +/- 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 29487213McNutt MK, Bradford M, Drazen JM, Hanson B, Howard B, Jamieson KH, Kiermer V, Marcus E, Pope BK, Schekman R, Swaminathan S, Stang PJ, Verma IM. Transparency in authors' contributions and responsibilities to promote integrity in scientific publication. Proc Natl Acad Sci U S A. 2018 Mar 13;115(11):2557-2560. doi: 10.1073/pnas.1715374115. Epub 2018 Feb 27.
- Background: PubMed 18498676McLean E, Cogswell M, Egli I, Wojdyla D, de Benoist B. Worldwide prevalence of anaemia, WHO Vitamin and Mineral Nutrition Information System, 1993-2005. Public Health Nutr. 2009 Apr;12(4):444-54. doi: 10.1017/S1368980008002401. Epub 2008 May 23.
- Background: PubMed 31197861Ferrer-Barcelo L, Sanchis Artero L, Sempere Garcia-Arguelles J, Canelles Gamir P, P Gisbert J, Ferrer-Arranz LM, Monzo Gallego A, Plana Campos L, Huguet Malaves JM, Lujan Sanchis M, Ruiz Sanchez L, Barcelo Cerda S, Medina Chulia E. Randomised clinical trial: intravenous vs oral iron for the treatment of anaemia after acute gastrointestinal bleeding. Aliment Pharmacol Ther. 2019 Aug;50(3):258-268. doi: 10.1111/apt.15327. Epub 2019 Jun 14.
- Background: PubMed 24251969Bager P, Dahlerup JF. Randomised clinical trial: oral vs. intravenous iron after upper gastrointestinal haemorrhage--a placebo-controlled study. Aliment Pharmacol Ther. 2014 Jan;39(2):176-87. doi: 10.1111/apt.12556. Epub 2013 Nov 19.
- Background: PubMed 25700159Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.
- Background: PubMed 30578747Sultan P, Bampoe S, Shah R, Guo N, Estes J, Stave C, Goodnough LT, Halpern S, Butwick AJ. Oral vs intravenous iron therapy for postpartum anemia: a systematic review and meta-analysis. Am J Obstet Gynecol. 2019 Jul;221(1):19-29.e3. doi: 10.1016/j.ajog.2018.12.016. Epub 2018 Dec 19.
- Background: PubMed 33362380Cotter J, Baldaia C, Ferreira M, Macedo G, Pedroto I. Diagnosis and treatment of iron-deficiency anemia in gastrointestinal bleeding: A systematic review. World J Gastroenterol. 2020 Dec 7;26(45):7242-7257. doi: 10.3748/wjg.v26.i45.7242.
- Derived from this study: PubMed 36918236Teutsch B, Vancsa S, Farkas N, Szakacs Z, Vorhendi N, Boros E, Szabo I, Hagendorn R, Alizadeh H, Hegyi P, Eross B. Intravenous ferric carboxymaltose versus oral ferrous sulfate replacement in elderly patients after acute non-variceal gastrointestinal bleeding (FIERCE): protocol of a multicentre, open-label, randomised controlled trial. BMJ Open. 2023 Mar 14;13(3):e063554. doi: 10.1136/bmjopen-2022-063554.
- Related InfoLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral iron supplementation and Intravenous iron supplementation in people with GastroIntestinal Bleeding and Anemia, run by University of Pecs at 1 site in Hungary.
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 8 inclusion and 14 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: opening soon, as of the sponsor's last update on 30 Mar 2025. 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 Hungary. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bálint Erőss, MD, PhD (+3630/887-4028, eross.balint@pte.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome (time frame: 3 months). 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 NCT05060731, which also lists 8 linked publications.
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 30 Mar 2025.