None listed
Conditions
Brief summary
• We are studying patients with anaemia who have had trauma surgery. • Anaemia is a deficiency in the number or quality of red blood cells. • Red blood cells carry oxygen around the body, using a protein called haemoglobin. • Anaemia exists when either the level of red blood cells or haemoglobin is lower than normal. • A treatment, involving a single intravenous (IV) injection of iron medication in hospital prior to discharge, is expected to improve the body’s ability to better correct anaemia. • This could result in a faster recovery, but we don’t not know if the IV iron injection truly works in people following trauma – this is why we are doing this trial.
Interventions
2 Arm study, Phase IV trial
1 arm will receive study drug, other arm will receive placebo. Both will be blinded by blacked out tubing and syringes
1 arm of the recruited trauma patients that are anaemic post-operatively will be given a single dose of ferric carboxymaltose 1,000 mg intravenous iron in 250mL of saline (up to a maximum of 20 mg iron/kg body weight). All patients will be given the maximum single dose of 1000mg unless their weight is <50Kg in which case the calculation will be appli
2 Arm study, Phase IV trial 1 arm will receive study drug, other arm will receive placebo. Both will be blinded by blacked out tubing and syringes 1 arm of the recruited trauma patients that are anaemic post-operatively will be given a single dose of ferric carboxymaltose 1,000 mg intravenous iron in 250mL of saline (up to a maximum of 20 mg iron/kg body weight). All patients will be given the maximum single dose of 1000mg unless their weight is <50Kg in which case the calculation will be applied to determine dose (20 mg iron/kg body weight). Infusion will be given once over 15 minutes by a member of the treating team at the Alfred Hospital so the study team remain blinded. The treatment will be administered on the ward prior to patients' discharge. The exact timing that each patient will the receive the treatment will vary, but it will be in the days following surgery while they are recovering on the ward.
Sponsors
Alfred Health - Department of Anaesthesiology and Perioperative Medicine
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients over the age of 18 admitted to the Alfred for treatment of trauma with post-operative anaemia at the time of enrolment.
Exclusion criteria
• Patient refusal • Iron transfusion prior to admission, surgery or intraoperatively • Hb <80 – these patients will be referred for treatment and transfusion • Patients with pre-existing haematological disorders or any condition associated with iron overload • Traumatic brain injury, neurological deficit or cognitive impairment that would impact compliance with surveys and follow up investigations • Patients with known hypersensitivity to IV iron
Outcome results
None listed