Effects of Rapid Administration of Iron Polymaltose in Patients with Anaemia, Under General Anaesthesia for Routine Surgery. The RAPID Trial”

Phase 4

• Conditions: Peri-operative Anaemia; Blood - Anaemia; Anaesthesiology - Other anaesthesiology

• Registration Number: ACTRN12612000423819
• Lead Sponsor: Fremantle Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Iron deficiency anaemia defined as Hb < 120g/L if female or Hb < 130g/L if male with ferritin < 100 or Iron deficiency alone, defined as ferritin < 30

Elective surgery / procedure requiring general anaesthesia

Exclusion Criteria

Pregnancy

Iron overload (haemochromatosis or haemosiderosis) or ferritin > 100

Clinically significant renal or liver disease

Chronic polyarthritis

Active infection

Allergy / intolerance to iron polymaltose

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of significant hypotension (i.e. systolic BP <80mmhg) and tachycardia (heart rate >100).<br><br>This will be measured using standard non-invasive blood pressure devices and a 3 lead ECG. All of this equipment is standardised anaesthetic monitoring in place for any general anaesthetic.[Haemodynamic data collection (BP and Heart Rate) at 5 minute intervals commencing before induction of anaesthesia and for 15 minutes following induction of anaesthesia. <br><br>Haemodynamic data collection (BP and Heart Rate) at 5 minute intervals commencing before commencement of iron polymaltose during the infusion (10 minutes) and for 15 minutes after completeion of the infusion.]

Secondary Outcome Measures

Name	Time	Method
Other adverse events.<br>Headache, nausea, flushing hypotension, muscle cramps.[Questionnaire at 2 hours post operatively. This is a general questionnaire asking about any other symptoms that may or may not be present. It is not intended to use a specific previously validated tool to assess this.]