Intravenous Iron for Correction of Anaemia After Colorectal Surgery

Summary

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.

Conditions

• Anemia, Iron-Deficiency
• Intravenous Drug Usage
• Colorectal Neoplasms
• Colorectal Surgery

Interventions

DRUG

Iron isomaltoside

Intravenous injection 1 g given postoperatively in the recovery ward. Blood tests including red blood cell count, plasma ferritin, haemoglobin, haematocrit, mean corpuscular volume, mean haemoglobin concentration are made 1 day preoperatively, day 1, day 3 postoperatively, day of discharge and 1 month after discharge. Reticulocyte count and reticulocyte haemoglobin concentration tests are made on the day of discharge and 1 month after discharge. Count of total consumption of intravenous blood products. Count of total intravenous fluids. Clinical recovery and complications. Duration of hospital stay.

DRUG

Saline

Intravenous injection given postoperatively in the recovery ward. Blood tests including red blood cell count, plasma ferritin, haemoglobin, haematocrit, mean corpuscular volume, mean haemoglobin concentration are made 1 day preoperatively, day 1, day 3 postoperatively, day of discharge and 1 month after discharge. Reticulocyte count and reticulocyte haemoglobin concentration tests are made on the day of discharge and 1 month after discharge. Count of total consumption of intravenous blood products. Count of total intravenous fluids. Clinical recovery and complications. Duration of hospital stay.

Sponsors & Collaborators

• Orivas, Lithuania

  collaborator UNKNOWN

• Pharmacosmos A/S

  collaborator INDUSTRY

• Kaunas University of Medicine

  lead OTHER

Principal Investigators

• Andrius Macas, MDPhDProf · Head of the Department of Anaesthesiology, Medical academy, Lithuanian University of Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-31

Primary Completion

2017-10-31

Completion

2018-10-31

Countries

• Lithuania

Study Locations