Does the use of iron given by injection improve the blood count before surgery in patients undergoing planned routine heart surgery

Phase 1

• Conditions: Anaemic patients undergoing elective cardiac surgeryAnaemia defined as follows:pre-operative haemoglobin levels in Female <11.5g/dl or Male <12.5g/dl; MedDRA version: 14.1Level: PTClassification code 10002034Term: AnaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-005666-35-GB
• Lead Sponsor: Royal Wolverhampton NHS trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-11
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Aged 18 yrs or older
Elective Cardiac surgery
Pre-operative Haemoglobin level >1g/dl below the normal range (i.e. women <11.5g/dl and men <12.5 g/dl)

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

a. Pregnancy/breast feeding women
b. Patient participating in another trial
c. Patients unable to give written consent.
d. Patients with a recognised allergy or other contraindication to intravenous iron or related products.
e. Low haemoglobin attributable to haemoglobinopathy
f. Anaemia secondary to known co-existing and uncorrected B12 or folate deficiency.
g. Patients already receiving intravenous iron treatment.
h. Patients with evidence of significant symptomatic anaemia which would normally require urgent transfusion at the time of assessment.
i. patients with a Hb less than 9.0 g/dl

Study & Design

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