The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients - the IVANOF1 Study
| ISRCTN | ISRCTN76424792 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76424792 |
| EudraCT/CTIS number | 2011-003233-34 |
| Secondary identifying numbers | 11206 |
- Submission date
- 05/09/2012
- Registration date
- 10/09/2012
- Last edited
- 29/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Iain Moppett
Scientific
Scientific
University of Nottingham
Department of Anaesthesia and Intensive Care
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
| iain.moppett@nottingham.ac.uk |
Study information
| Study design | Randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients a pilot study |
| Study acronym | IVANOF1 |
| Study objectives | Anaemia following hip fracture is common. Approximately 30-45 % of patients have haemoglobin concentrations ([Hb]) below population norms on admission and around 10% are severely anaemic. Anaemia on admission and in the postoperative period is associated with poor outcome with regard to mobility, postoperative mortality and readmission. There is currently no clear consensus on the optimal method to manage peri-operative anaemia in this frail group of patients with frequent comorbidity. Liberal red cell transfusion in the postoperative period does not appear to improve outcome and tranexamic acid appears to reduce transfusion rate at the expense of increased cardiovascular morbidity. There are encouraging results from one centre with the use of agents to stimulate red cell production, including intravenous iron and erythropoietin. UK practice has significant differences to the patients and these studies and it is not clear whether these promising results will translate to the UK population. More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11206 |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Blood, Injuries and Emergencies |
| Intervention | Single-centre randomised controlled parallel group trial. Randomisation by website using computer generated concealed tables. Setting: University hospital in UK. Participants: 80 patients with acute hip fracture undergoing operative repair and aged > 70 years. Intervention: Three daily infusions of 200mg iron sucrose starting within 24 hours of admission. Control group: standard hospital care at the discretion of the clinical team. Red cell transfusions for each group are given in accordance with standard clinical triggers. Primary outcome: difference in mean reticulocyte count between groups at day 7. Secondary outcomes include: haemoglobin concentrations, early and late transfusion rates, infectious and cardiovascular complications, mobility and 30-day mortality. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Reticulocyte count measured at day 7 |
| Secondary outcome measures | 1. Infective complications 2. Length of actue hospital stay 3. Minimum haemoglobin 4. Mortality within first 7 days 5. Mortality within first 30 days 5. Safety variables 6. Transfusion requirements 7. Pre-operative transfusion 8. Postoperative transfusion 9. Late transfusion (> day 7) |
| Overall study start date | 12/06/2012 |
| Completion date | 12/03/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | UK Sample Size: 80 |
| Total final enrolment | 80 |
| Key inclusion criteria | 1. Primary hip fracture 2. Aged over 70 3. Able to consent for themselves 4. Male and female participants |
| Key exclusion criteria | 1. Undisplaced intracapsular fractures (very low transfusion requirements 2. Contraindications to intravenous iron 3. Currently taking antiplatelet drugs other than aspirin |
| Date of first enrolment | 12/06/2012 |
| Date of final enrolment | 12/03/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Nottingham
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
University Park
Nottingham
NG7 2RD
England
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Research organisation
National Institute of Academic Anaesthesia [NIAA] (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/09/2013 | Yes | No | |
| Basic results | 15/11/2018 | 15/11/2018 | No | No | |
| Results article | results | 01/09/2019 | 29/05/2019 | Yes | No |
Additional files
- ISRCTN76424792_BasicResults_15Nov18.pdf
- Uploaded 15/11/2018
Editorial Notes
The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
15/11/2018: The basic results of this trial have been uploaded as an additional file.
23/10/2018: No publications found, verifying study status with principal investigator.
