The role of intravenous iron for patients with anaemia around the time of surgery

The role of intravenous iron compared to standard treatment for patients booked for major abdominal surgery with anaemia around the time of surgery in reduction in allogeneic red cell transfusion".

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000387921

Enrollment

Registered

2011-04-13

Start date

2011-08-27

Completion date

2014-10-23

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

investigators decided to decline the sponsorship offer.

Interventions

Patients randomized to the intervention group will be exposed to intravenenous admistration of Ferric carboxymaltose before (1000mg or max 15mg /kg) and after surgery (50mg per 100ml estimated blood loss)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Anaemia Hb, Ferritin <300 micro g/L female<120 gram/L, Transferrin Sat <25% male<130 gram/L

Exclusion criteria

Other causes of anaemia – haemaglobinopahty, GI bleeding, acute systemic infection, vitamin B12 or folate deficiency, hepatitis, HIV No consent Severe asthma Allergy to iron Pre-treatment ferritin levels > 300 ng/ml

Outcome results