Intravenous iron for treatment of anaemia before cardiac surgery

Phase 1

• Conditions: Anaemia; MedDRA version: 20.0Level: PTClassification code 10022972Term: Iron deficiency anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-004439-19-GB
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-06
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1) Adult patients (=18 years)
2) Patients with anaemia (males (Hb) <130g/L, females <120g/L) undergoing elective cardiac surgery, and able to receive trial drug 1-10 weeks prior to planned surgery
3) Negative pregnancy test for women of childbearing age (within last 7 days), and agree to use effective form of contraception (e.g. hormonal contraception, intrauterine device/hormone-release system, bilateral tubal occlusion, vasectomised partner, sexual abstinence) until 6 weeks post treatment
4) Able to provide written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1) Pregnant, planning pregnancy, lactating or breast-feeding
2) Known hypersensitivity to study drug (Iron isomaltoside 1,000 or equivalent) or its excipients
3) Previously documented TSAT >50%
4) Known or suspected haemoglobinopathy/thalassaemia
5) Known and untreated cause for anaemia such as B12 deficiency.
6) Renal dialysis (current or planned within the next 12 months)
7) Erythropoietin or IV iron in the previous 4 weeks
8) Ongoing bacteraemia (as confirmed in accordance with routine investigations for septic work up such as FBC, blood cultures, urine and stool MCS)
9) Temperature >37.5°C
10) Decompensated liver cirrhosis and hepatitis
11) Body weight <50kg

Note: Oral iron (tablets, capsules) therapy is not an exclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 30 days following operation;Main Objective: To determine whether a single dose of intravenous iron, given to anaemic patients before elective cardiac surgery improves outcome after surgery. ;Secondary Objective: To demonstrate that intravenous iron is cost-effective in this setting. <br><br>To identify biomarkers that predict iron-responsiveness in the preoperative setting, and to better understand mechanisms of functional iron deficiency in surgical patients with heart disease.;Primary end point(s): Days alive and out of hospital (DAOH) from surgery to 30 days following operation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): a) Correction of anaemia (?Hb) from day of enrolment to day of surgery (preoperative) <br>b) Correction of iron deficiency state (?Ferritin, ?TSAT) from treatment to operation <br>c) Units of allogeneic blood transfused - preoperative, post-operation (day 1), post-operation (day 3), Day of discharge<br>d) Postoperative complications - during hosptial stay<br>e) Intensive care unit and hospital stay <br>f) Disability-free survival, from day of surgery to 6 months after surgery <br>g) 90-day survival, from day of enrolment <br>h) Patient reported quality of life will be assessed by the MacNew Heart Disease Questionnaire (preoperatively) and EQ-5D, and disability using WHODAS. Patients will be assessed at baseline, before operation, at discharge, Day 30, and at 3 and 6 months after surgery. ;Timepoint(s) of evaluation of this end point: Please see E5-2<br>