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Iron Supplementation in Upper Non-variceal Gastrointestinal Bleeding

ConditionsGastroIntestinal BleedingAnemia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Pecs

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥ 65 years;

endoscopically proven acute nonvariceal GIB source;

48 hours after the endoscopic diagnosis and/or treatment;

hemodynamically stable;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral iron supplementation

    Drug

    Ca. 200-300 mg of ferrous sulfate will be administered orally every day for 3 months.

  • Intravenous iron supplementation

    Drug

    One dose of intravenous 1000 mg ferric carboxymaltose will be administered on the day of randomization.

Treatment groups

570 Participants
are divided into 2 treatment groups
Group A: Oral iron supplementationActive comparator 1 intervention
Group B: Intravenous iron supplementationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months

Secondary outcomes

1

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.

Time frame
1, and 3 months
2

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.

Time frame
1, and 3 months
3

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.

Time frame
1, and 3 months
4

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.

Time frame
1, and 3 months +/- 7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pecs

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: