Rapid Administration of iron Polymaltose whilst In the operating Department for patients with iron deficiencyThe RAPID Study
Phase 4
Completed
- Conditions
- Blood - Other blood disordersIron deficiencyBlood - Anaemia
- Registration Number
- ACTRN12613000356763
- Lead Sponsor
- Dr Roger M Browning
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Female Hb < 120 g/L and ferritin < 100
Male Hb < 130 g/L and ferritin < 100
Iron deficiency alone ferritin < 30
Undergoing general anaesthesia for a procedure
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 The proportion of patients with systolic BP less than 80mmHg during iron infusion compoared to the proportion of patients with systolic BP less than 80mmHg in the first 15 min after induction of anaesthesia. Statistical comparison using fishers exact test.[First 15 min after induction of anaesthesia compared to 30min period around iron infusion (15min during and 15min after)]
- Secondary Outcome Measures
Name Time Method Absolute difference in systolic blood pressure change during iron infusion compared to after induction of anaesthesia. Statistical analysis using t-test to compare measured difference.[First 15 min after induction of anaesthesia compared to 30min period around iron infusion (15min during and 15min after)]