Download PDF

Clinical Trial Results:
Can Intravenous Iron Reduce Transfusion rates in Anaemic patients undergoing Cardiac Surgery

Summary
EudraCT number	2012-005666-35
Trial protocol	GB
Global end of trial date	08 Feb 2019

Results information
Results version number	v1(current)
This version publication date	23 Dec 2021
First version publication date	23 Dec 2021
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

2012-003-0301-CARD

ISRCTN number

ISRCTN22158788

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

The Royal Wolverhampton NHS Trust

Sponsor organisation address

New Cross Hospital, Wolverhampton, United Kingdom, WV10 0QP

Public contact

Lorraine Jacques, Royal Wolverhampton NHS trust, 01902 307999, lorraine.jacques@nhs.net

Scientific contact

Lorraine Jacques, Royal Wolverhampton NHS trust, 01902 307999, lorraine.jacques@nhs.net

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

31 Dec 2015

Is this the analysis of the primary completion data?

Yes

Primary completion date

31 Dec 2015

Global end of trial reached?

Yes

Global end of trial date

08 Feb 2019

Was the trial ended prematurely?

Main objective of the trial

To assess the effect of pre-operative intravenous ferric carboxymaltose(Ferinject) therapy as compared to current practice(oral iron 200mg BD), on pre-operative haemoglobin levels in anaemic (Female <11.5g/dl or Male <12.5g/dl) patients undergoing elective cardiac surgery. Does its use lead to an increase in the patient's haemoglobin pre-surgery?

Protection of trial subjects

The inconvenience to participants has been kept to a minimum by scheduling the screening blood test to coincide with the routine surgical outpatient appointment. Consent and intravenous iron therapy as well as the questionnaires will all be administered at the time of the preoperative admission clinic visit. The effect of the intravenous iron therapy on Hb levels will be assessed at the time of admission for surgery. Finally, the postoperative questionnaires will completed at the time of the postop visit to OPD. Hence patients will not need any additional hospital visit. The administration of intravenous iron can sometimes result in local skin reactions and slight discomfort and gastrointestinal disturbances. The participants will be advised of what to expect and be given contact details of members of the research team to contact if they require any advice.

Background therapy

Evidence for comparator

Actual start date of recruitment

03 Oct 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 50

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

50 recruited. 03/10/2013 recruitment start date 31/12/2015 recruitment end date

Screening details

2626 patients were screened. Prior to study entry, each patient’s inclusion/exclusion criteria was checked. Our database shows that every year around 20% of elective all cardiac surgical patients was eligible

Period 1 title

Overall Trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

IV Ferric carboxymaltose (Ferinject) group

Arm description

Patients randomised to IV iron

Arm type

Active comparator

Investigational medicinal product name

Ferric carboxymaltose

Investigational medicinal product code

Other name

Ferinject

Pharmaceutical forms

Injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Intravenous, 1 Gram

Control

Arm description

Standard current practice (Oral iron 200mg bd).

Arm type

Active comparator

Investigational medicinal product name

Iron

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

200mg bd

Number of subjects in period 1	IV Ferric carboxymaltose (Ferinject) group	Control
Started	26	24
Completed	26	24

Baseline characteristics

Top of page

Reporting group title

IV Ferric carboxymaltose (Ferinject) group

Reporting group description

Patients randomised to IV iron

Reporting group title

Control

Reporting group description

Standard current practice (Oral iron 200mg bd).

Reporting group values	IV Ferric carboxymaltose (Ferinject) group	Control	Total
Number of subjects	26	24	50
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	16	10	26
From 65-84 years	10	14	24
85 years and over	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	73 ± 12	75 ± 10	-
Gender categorical
Units: Subjects
Female	11	9	20
Male	15	15	30

End points

Top of page

Reporting group title

IV Ferric carboxymaltose (Ferinject) group

Reporting group description

Patients randomised to IV iron

Reporting group title

Control

Reporting group description

Standard current practice (Oral iron 200mg bd).

Primary: change in haemoglobin concentration before and approximately 3 weeks after iron therapy

Top of page

End point title

change in haemoglobin concentration before and approximately 3 weeks after iron therapy

End point description

End point type

Primary

End point timeframe

3 weeks

End point values	IV Ferric carboxymaltose (Ferinject) group	Control
Number of subjects analysed	26	24
Units: g/l
median (inter-quartile range (Q1-Q3))	1 (-3.25 to 7.25)	3 (-1.25 to 6.25)

haemoglobin increment

Comparison groups

IV Ferric carboxymaltose (Ferinject) group v Control

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.42

Method

t-test, 2-sided

Confidence interval

Adverse events

Top of page

Timeframe for reporting adverse events

Up to 8 weeks after surgery

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

IV Ferric carboxymaltose (Ferinject) group

Reporting group description

Patients randomised to IV iron

Reporting group title

Control

Reporting group description

Standard current practice (Oral iron 200mg bd).

Serious adverse events	IV Ferric carboxymaltose (Ferinject) group	Control
Total subjects affected by serious adverse events
subjects affected / exposed	16 / 26 (61.54%)	9 / 24 (37.50%)
number of deaths (all causes)	1	0
number of deaths resulting from adverse events	0	0
Cardiac disorders
Chest pain
subjects affected / exposed	2 / 26 (7.69%)	0 / 24 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	1 / 26 (3.85%)	1 / 24 (4.17%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	1 / 26 (3.85%)	0 / 24 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Heart block congenital
subjects affected / exposed	0 / 26 (0.00%)	1 / 24 (4.17%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tachyarrhythmia
subjects affected / exposed	1 / 26 (3.85%)	0 / 24 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Tooth extraction
subjects affected / exposed	1 / 26 (3.85%)	0 / 24 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Dizziness
subjects affected / exposed	1 / 26 (3.85%)	0 / 24 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Confusional state
subjects affected / exposed	1 / 26 (3.85%)	0 / 24 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	1 / 26 (3.85%)	0 / 24 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	0 / 26 (0.00%)	1 / 24 (4.17%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Cellulitis
subjects affected / exposed	0 / 26 (0.00%)	1 / 24 (4.17%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	0 / 26 (0.00%)	1 / 24 (4.17%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bleeding time abnormal
subjects affected / exposed	1 / 26 (3.85%)	0 / 24 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Tumour excision
subjects affected / exposed	0 / 26 (0.00%)	1 / 24 (4.17%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pleural effusion
subjects affected / exposed	1 / 26 (3.85%)	3 / 24 (12.50%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Emphysema
subjects affected / exposed	1 / 26 (3.85%)	0 / 24 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	1 / 26 (3.85%)	0 / 24 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Infection
Additional description: Chest Infection
subjects affected / exposed	1 / 26 (3.85%)	0 / 24 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	IV Ferric carboxymaltose (Ferinject) group	Control
Total subjects affected by non serious adverse events
subjects affected / exposed	0 / 26 (0.00%)	3 / 24 (12.50%)
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	0 / 26 (0.00%)	3 / 24 (12.50%)
occurrences all number	0	3
Constipation
subjects affected / exposed	0 / 26 (0.00%)	3 / 24 (12.50%)
occurrences all number	0	3

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

01 Oct 2014

In July 2014 we received approval for the following elements (1 & 2) 1. Changes in eligibility criteria: 2. Platelet analysis: Unfortunately we have problems with funding with respect to the second element. We continued recruiting patients using first element (Changes in eligibility criteria) and remove the second element (Platelet analysis) from the study.

13 Jan 2016

Study poster added

07 Feb 2017

Additional analysis of the stored serum samples: Addition of measuring platelet count, soluble P-selectin and any potential serum or plasma biomarkers which might influence iron metabolism.

04 Oct 2017

Alteration to PI

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

http://www.ncbi.nlm.nih.gov/pubmed/30107449

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Clinical trials

Clinical Trial Results:
Can Intravenous Iron Reduce Transfusion rates in Anaemic patients undergoing Cardiac Surgery

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: change in haemoglobin concentration before and approximately 3 weeks after iron therapy

Primary: change in haemoglobin concentration before and approximately 3 weeks after iron therapy

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: Can Intravenous Iron Reduce Transfusion rates in Anaemic patients undergoing Cardiac Surgery

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: change in haemoglobin concentration before and approximately 3 weeks after iron therapy

Primary: change in haemoglobin concentration before and approximately 3 weeks after iron therapy

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
Can Intravenous Iron Reduce Transfusion rates in Anaemic patients undergoing Cardiac Surgery