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Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

ConditionsGastric CancerAnemiaSurgeryIron Deficiency AnemiaSurgery--Complications
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelsinki University Central Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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%

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ferric carboxymaltose

    Drug

    Ferric carboxymaltose iv infusion

  • Placebos

    Drug

    NaCl 0.9% infusion

Treatment groups

202 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The need for blood transfusion

Number of patients needing transfusions

Time frame
Within 30 days from the day of the operation

Secondary outcomes

1

Postoperative complications

Postoperative complications measured using Comprehensive complication index

Time frame
Within 30 days from operation
2

Patients' quality of life (RAND)

RAND questionnaires

Time frame
One and six months after the surgery
3

Patients' quality of life (15D)

15D questionnaires

Time frame
One and six months after the surgery
4

Patients' quality of life (EQ-5D)

EQ-5D questionnaires

Time frame
One and six months after the surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Helsinki University Central Hospital

Lead sponsor

Source ClinicalTrials.gov

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