Intravenous Iron for Correction of Anaemia After Colorectal Surgery

Kaunas University of Medicine

Status and phase: Unknown; Phase 4

Conditions: Anemia, Iron-Deficiency; Colorectal Surgery; Colorectal Neoplasms; Intravenous Drug Usage

Treatments: Drug: Saline; Drug: Iron isomaltoside

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02999217

BEC-MF-74

Details and patient eligibility

About

This 4-week prospective double blind anaemia management study evaluates the effect of high-dose postoperative intravenous iron vs placebo for patients after colorectal cancer surgery. Patients with preoperative levels of haemoglobin 90-120 g/l will be randomly assigned to receive either 1 g of intravenous iron or equal amount of saline postoperatively. Comparison will be based on the levels of haemoglobin, ferritin and other haematological parameters over time and profile of clinical recovery.

The primary end point is that iron isomaltoside given postoperatively is superior to placebo in terms of increase and stability of levels of haemoglobin and other haematological parameters.

Full description

The Aim: to assess the effect of treatment of preoperative anaemia with intravenous iron on haematological parameters for patients after elective colorectal surgery.

Primary Hypothesis: postoperative treatment with intravenous iron increases the levels of haemoglobin, ferritin, red cell count and is superior compared to placebo.

Secondary effects: treatment with intravenous iron vs placebo provides reduction of blood transfusions, postoperative complications and hospital stay.

The Objectives:

1. To estimate the rate of preoperative anaemia in patients of elective colorectal surgery.
2. To assess the dynamic changes of total blood count values in colorectal surgery patients treated with postoperative intravenous iron.
3. To compare the changes in total blood count values over time in colorectal surgery patients treated with intravenous iron versus colorectal surgery patients of the control group.

Methods:

The prospective, double-blinded study includes American Society of Anaesthesiology (ASA) I-III patients, aged 18-75 years, admitted for elective colorectal surgery. Preoperatively, patients with levels of haemoglobin 90-120 g/l will be identified and their serum ferritin will be tested. In cases of ferritin<100 mkg/l, patients will be blindly randomized into one of the two groups: treatment group (group T) is given 1000 mg of intravenous iron (iron isomaltoside, Orivas, Pharmacosmos) in the postoperative recovery ward and control group (group C) which is given the same volume of intravenous saline (placebo).

Patients in both groups will be provided with general anaesthesia (fentanyl, propofol, atracurium, inhaled sevoflurane for maintenance) and after tracheal extubation will be transferred to the recovery ward.

Patient blood tests: total blood count, haemoglobin, haematocrit, mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), plasma ferritin) will be assessed in both groups 1 day preoperatively, day 1 and 3 postoperatively, the day of discharge and 4 weeks after discharge from the department of surgery. The level of reticulocyte and reticulocyte haemoglobin concentration will be determined on the day of discharge and 4 weeks after discharge.

According to the study protocol, groups will also be compared in terms of clinical recovery, requirements of intravenous fluids and blood transfusion and duration of hospital stay.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective colorectal cancer surgery
• preoperative haemoglobin 90-120 g/l
• preoperative plasma ferritin <100 mkg/l

Exclusion criteria

• laparoscopic colorectal surgery
• body mass <50kg
• history of overdosage of iron products
• family history of haemochromatosis, thalassaemia,
• non-iron deficiency anaemia (Vit. B12, folic acid defficiency, haemoglobinopathies)
• under treatment with erythropoietin, intravenous iron or blood transfusion in the last 12 weeks
• allergy to iron carboxymaltose or its supplements
• body temperature > 37.5 °C or under antibiotic use
• chronic liver diseases or/and increased levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times over normal upper limit
• patients ill with grave bronchial asthma
• patients with manifestation of allergy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Treatment

Active Comparator group

Description:

1 g of intravenous iron isomaltoside given postoperatively for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin\<100 mkg/l).

Treatment:

Drug: Iron isomaltoside

Control

Placebo Comparator group

Description:

The same amount of intravenous saline for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin\<100 mkg/l).

Treatment:

Drug: Saline