Clinical trial NCT04168346: Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer
Official title: Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Gastric Cancer
Anemia
Surgery
Iron Deficiency Anemia
Surgery--Complications
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

- Patients with gastric cancer who will undergo a gastrectomy

Exclusion Criteria:

* Patients under 18 years old
* Patients not in full understanding
* 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.
* Transferrin saturation level \>50%
* Emergency gastrectomy
* Palliative gastrectomy
* Acute bacterial infection
* Known hypersensitivity to the active substance, to ferric carboxymaltose or any of its excipients, or to other parental iron products
* Clinical evidence of iron overload or disturbances in the utilisation of iron
* Patients \<35 kg
* Dialysis therapy for chronic renal failure
* Hemochromatosis
* Polycythemia vera
* Pregnancy
* 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)

Primary outcomes:
measure: The need for blood transfusion
timeFrame: Within 30 days from the day of the operation
Secondary outcomes:
measure: Postoperative complications
timeFrame: Within 30 days from operation
measure: Patients' quality of life (RAND)
timeFrame: One and six months after the surgery
measure: Patients' quality of life (15D)
timeFrame: One and six months after the surgery
measure: Patients' quality of life (EQ-5D)
timeFrame: One and six months after the surgery
measure: Patients' quality of life (FRAIL)
timeFrame: One and six months after the surgery
measure: Patients' quality of life (PRISMA-7)
timeFrame: One and six months after the surgery
measure: Patients' quality of life (GSRS)
timeFrame: One and six months after the surgery
measure: Patients' quality of life (IDQ)
timeFrame: One and six months after the surgery
measure: Patients' haemoglobin and iron parameter levels
timeFrame: At the time of hospital discharge (estimated on average 10 days after surgery)
measure: Patients' haemoglobin and iron parameter levels
timeFrame: One month after the surgery
measure: Patients' haemoglobin and iron parameter levels
timeFrame: Three months after the surgery
measure: Re-admission
timeFrame: 30 days after discharge from hospital
measure: 90-day mortality
timeFrame: Within 90 days from operation
measure: Overall survival
timeFrame: 1, 3 and 5 years from operation
measure: Length of hospital stay
timeFrame: Within hospital stay, on average 7 - 14 days
measure: Use of IV iron after operation
timeFrame: Within 3 months from operation
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Arto Kokkola, MD
role: STUDY_DIRECTOR
References: