The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients: study protocol for a randomized controlled trial
Background Anaemia following hip fracture is common. Approximately 30 to 45% of patients have haemoglobin concentrations below population norms on admission, and around 10% are severely anaemic. Anaemia on admission, and in the postoperative period, is associated with poor outcomes with regard to m...
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BioMed Central
2013
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| Online Access: | https://eprints.nottingham.ac.uk/2607/ |
| _version_ | 1848790829330595840 |
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| author | Rowlands, Martin Forward, Daren P. Sahota, Opinder Moppett, Iain K. |
| author_facet | Rowlands, Martin Forward, Daren P. Sahota, Opinder Moppett, Iain K. |
| author_sort | Rowlands, Martin |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | Background
Anaemia following hip fracture is common. Approximately 30 to 45% of patients have haemoglobin concentrations below population norms on admission, and around 10% are severely anaemic. Anaemia on admission, and in the postoperative period, is associated with poor outcomes with regard to mobility, postoperative mortality and readmission. There is currently no clear consensus on the optimal method of managing perioperative anaemia in this group of frail patients with frequent comorbidity. Liberal red cell transfusion in the postoperative period does not appear to improve outcome, whereas 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 differs significantly from these patients and these studies, and it is not clear whether these promising results will translate to the UK population.
Methods/Design
This is a single-centre randomized controlled parallel group trial, in a British university hospital.Randomization is achieved using a website and computer-generated concealed tables. Participants are 80 patients 70 years or over with acute hip fracture undergoing operative repair. The intervention group receive three daily infusions of 200 mg iron sucrose, starting within 24 hours of admission. The control group receive standard hospital care at the discretion of the clinical team. Red cell transfusions for each group are given in accordance with standard clinical triggers. The primary outcome is an increase in mean reticulocyte count in the intervention group at day 7. Secondary outcome measures include haemoglobin concentrations, early and late transfusion rates, infectious and cardiovascular complications, mobility and 30-day mortality.
Discussion
This is a pilot study to demonstrate haematopoietic efficacy of intravenous iron in this setting. Hence, we have chosen to measure change in reticulocyte count rather than the more clinically relevant differences in haemoglobin concentration or transfusion rate. If our results are positive, the study will provide the necessary information for development of a full-scale trial of intravenous iron.
Trial registration
Current Controlled Trials ISRCTN76424792; UK Medicines and Healthcare products Regulatory Authority (EuDRACT: 2011-003233-34). |
| first_indexed | 2025-11-14T18:18:50Z |
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| id | nottingham-2607 |
| institution | University of Nottingham Malaysia Campus |
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| last_indexed | 2025-11-14T18:18:50Z |
| publishDate | 2013 |
| publisher | BioMed Central |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-26072020-05-04T16:38:57Z https://eprints.nottingham.ac.uk/2607/ The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients: study protocol for a randomized controlled trial Rowlands, Martin Forward, Daren P. Sahota, Opinder Moppett, Iain K. Background Anaemia following hip fracture is common. Approximately 30 to 45% of patients have haemoglobin concentrations below population norms on admission, and around 10% are severely anaemic. Anaemia on admission, and in the postoperative period, is associated with poor outcomes with regard to mobility, postoperative mortality and readmission. There is currently no clear consensus on the optimal method of managing perioperative anaemia in this group of frail patients with frequent comorbidity. Liberal red cell transfusion in the postoperative period does not appear to improve outcome, whereas 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 differs significantly from these patients and these studies, and it is not clear whether these promising results will translate to the UK population. Methods/Design This is a single-centre randomized controlled parallel group trial, in a British university hospital.Randomization is achieved using a website and computer-generated concealed tables. Participants are 80 patients 70 years or over with acute hip fracture undergoing operative repair. The intervention group receive three daily infusions of 200 mg iron sucrose, starting within 24 hours of admission. The control group receive standard hospital care at the discretion of the clinical team. Red cell transfusions for each group are given in accordance with standard clinical triggers. The primary outcome is an increase in mean reticulocyte count in the intervention group at day 7. Secondary outcome measures include haemoglobin concentrations, early and late transfusion rates, infectious and cardiovascular complications, mobility and 30-day mortality. Discussion This is a pilot study to demonstrate haematopoietic efficacy of intravenous iron in this setting. Hence, we have chosen to measure change in reticulocyte count rather than the more clinically relevant differences in haemoglobin concentration or transfusion rate. If our results are positive, the study will provide the necessary information for development of a full-scale trial of intravenous iron. Trial registration Current Controlled Trials ISRCTN76424792; UK Medicines and Healthcare products Regulatory Authority (EuDRACT: 2011-003233-34). BioMed Central 2013-09-09 Article PeerReviewed Rowlands, Martin, Forward, Daren P., Sahota, Opinder and Moppett, Iain K. (2013) The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients: study protocol for a randomized controlled trial. Trials, 14 . 8/1-8/8. ISSN 1745-6215 Aged 70 and over Anaemia Iron deficiency Ferric compounds administration and dosage Ferric compounds therapeutic use Hip fractures surgery Human beings Perioperative period Postoperative complications drug therapy http://www.trialsjournal.com/content/14/1/288 doi:10.1186/1745-6215-14-288 doi:10.1186/1745-6215-14-288 |
| spellingShingle | Aged 70 and over Anaemia Iron deficiency Ferric compounds administration and dosage Ferric compounds therapeutic use Hip fractures surgery Human beings Perioperative period Postoperative complications drug therapy Rowlands, Martin Forward, Daren P. Sahota, Opinder Moppett, Iain K. The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients: study protocol for a randomized controlled trial |
| title | The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients: study protocol for a randomized controlled trial |
| title_full | The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients: study protocol for a randomized controlled trial |
| title_fullStr | The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients: study protocol for a randomized controlled trial |
| title_full_unstemmed | The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients: study protocol for a randomized controlled trial |
| title_short | The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients: study protocol for a randomized controlled trial |
| title_sort | effect of intravenous iron on postoperative transfusion requirements in hip fracture patients: study protocol for a randomized controlled trial |
| topic | Aged 70 and over Anaemia Iron deficiency Ferric compounds administration and dosage Ferric compounds therapeutic use Hip fractures surgery Human beings Perioperative period Postoperative complications drug therapy |
| url | https://eprints.nottingham.ac.uk/2607/ https://eprints.nottingham.ac.uk/2607/ https://eprints.nottingham.ac.uk/2607/ |