NCT04168346Not yet recruitingPhase 4
Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer
Source: ClinicalTrials.gov · Last updated 19 Nov 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The main objective of this investigator initiated study is to study if preoperative intravenous iron is effective in reducing need for allogenic blood transfusion in patients with gastric cancer who will undergo a standardized gastrectomy including both total and subtotal gastrectomies. The hypothesis is that intravenous iron reduces the need for perioperative blood transfusions.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 202 (estimated)
- First submitted
- 12 Nov 2019
- Start date
- Nov 2019
- Primary completion date
- Nov 2021
- Lead sponsor
- Helsinki University Central Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04168346
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 202
- From Nov 2019 to the primary completion date, Nov 2021
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Acute bacterial infection
- Known hypersensitivity to the active substance, to ferric carboxymaltose or any of its excipients, or to other parental iron products
- Dialysis therapy for chronic renal failure
Lab values
- Hemoglobin levels \> 155 g/l for women and \>167 g/l for men (upper reference limits for the laboratory of Helsinki University Hospital district) preoperatively.
- Patients in need of direct blood transfusion ( Criteria for this are hemoglobin \< 80 g/l or \< 90 g/l if the patient is symptomatic or has a history of heart disease)
Age
- Patients under 18 years old
Other
- Patients not in full understanding
- Transferrin saturation level \>50%
- Emergency gastrectomy
- Palliative gastrectomy
- Clinical evidence of iron overload or disturbances in the utilisation of iron
- Patients \<35 kg
- Hemochromatosis
- Polycythemia vera
- Pregnancy
Who the study is looking for
- \- Patients with gastric cancer who will undergo a gastrectomy
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.