Skip to main content

Improved patient blood management and cost saving in hip replacement surgery through the implementation of pre-operative Sucrosomial® iron supplementation: a quality improvement assessment study

Abstract

Purpose

To compare post-operative recovery of prosthetic hip surgery patients with or without the implementation of iron supplementation with a new highly absorbable oral iron formulation.

Methods

Observational retrospective quality improvement assessment conducted on patients who had undergone elective prosthetic hip surgery (first implant) with ferritin < 100 mcg/dl and Hb values between 13 and 14 g/dl for men and 12 g/dl and 13.5 g/dl for women, or having ferritin levels > 100 mcg/dl but C-reactive protein (CRP) > 3 mg/l and transferrin saturation (TSAT) < 20%, which together are suggestive of functional iron deficiency. The analysis compared a group of non-anaemic patients having ferritin levels > 100 mcg/l to two groups of patients with iron deficiency, of which only one received iron supplementation. Measurements included haemoglobin levels, length of hospital stay, and number of transfused patients/blood units.

Results

Patients with iron deficiency supplemented with Sideral® Forte compared to non-supplemented patients showed a smaller decline in post-operative Hb (9.7 ± 1.24 g/dl vs 8.4 ± 0.6 g/dl), required shorter hospital stay (4 vs 6.5 days) and less blood transfusions (0 in the iron-supplemented group vs 7 units in the non-iron-supplemented group), yielding an overall savings of 1763.25 €/patient.

Conclusions

Pre-operative sucrosomial iron supplementation at least 4 weeks prior to elective surgery in non-anaemic patients limits the drop in post-operative Hb levels, determining higher post-operative haemoglobin, quicker post-surgical recovery, shorter hospitalisation, and decreased surgery-related costs.

This is a preview of subscription content, access via your institution.

References

  1. 1.

    Musallam KM, Tamim HM, Richards T, Spahn DR, Rosendaal FR, Habbal A et al (2011) Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective cohort study. Lancet 378:1396–1407. https://doi.org/10.1016/S0140-6736(11)61381-0

    Article  Google Scholar 

  2. 2.

    Cuenca J, Garcia-Erce JA, Martinez F, Cardona R, Perez-Serrano L, Munoz M (2007) Preoperative haematinics and transfusion protocol reduce the need for transfusion after total knee replacement. Inter J Surg 5:89–94. https://doi.org/10.1016/j.ijsu.2006.02.003

    Article  Google Scholar 

  3. 3.

    Halm EA, Wang JJ, Boockvar K, Penrod J, Silberzweig SB, Magaziner J et al (2004) The effect of perioperative anemia on clinical and functional outcomes in patients with hip fracture. J Ortho Traum 18:369–374

    Article  Google Scholar 

  4. 4.

    Lasocki S, Krauspe R, von Heymann C, Mezzacasa A, Chainey S, Spahn D (2015) PREPARE: the prevalence of perioperative anaemia and need for patient blood management in elective orthopaedic surgery: a multicentre, observational study. EJA 32:160–167. https://doi.org/10.1097/EJA.0000000000000202

    Article  Google Scholar 

  5. 5.

    Munoz M, Gomez-Ramirez S, Kozek-Langeneker S (2016) Pre-operative haematological assessment in patients scheduled for major surgery. Anaesthesia 71(Suppl 1):19–28. https://doi.org/10.1111/anae.13304

    Article  PubMed  Google Scholar 

  6. 6.

    Spahn DR (2010) Anemia and patient blood management in hip and knee surgery: a systematic review of the literature. Anesthesiology 113:482–495. https://doi.org/10.1097/ALN.0b013e3181e08e97

    Article  Google Scholar 

  7. 7.

    Barni S (2015) 3rd Mediterranean Multidisciplinary Course on Iron Anemia April, 17(th)-18(th) 2015, Rome, Italy. Expert Rev Hematol 8(Suppl 1):S1–S32 doi.org/10.1586/17474086.2015.1044965

    Google Scholar 

  8. 8.

    Munoz M, Gomez-Ramirez S, Campos A, Ruiz J, Liumbruno G (2015) Pre-operative anaemia: prevalence, consequences and approaches to management. Blood Transfus 13:370–379. https://doi.org/10.2450/2015.0014-15

    Article  PubMed  PubMed Central  Google Scholar 

  9. 9.

    Vanderlinde ES, Heal JM, Blumberg N (2002) Autologous transfusion. Br Med J (Clin Res Ed) 324:772–775

    Article  Google Scholar 

  10. 10.

    Kendoff D, Tomeczkowski J, Fritze J, Gombotz H, von Heymann C (2011) Präoperative Anämie in der Orthopädie [Preoperative anemia in orthopedic surgery: clinical impact, diagnostics and treatment]. Der Orthopade 40:1018–1028 [article in German]

    Article  CAS  PubMed  Google Scholar 

  11. 11.

    Hochreiter J, Hejkrlik W, Emmanuel K, Hitzl W, Ortmaier R (2017) Blood loss and transfusion rate in short stem hip arthroplasty. A comparative study. Int Orthop 41(7):1347–1353. https://doi.org/10.1007/s00264-016-3365-2

    Article  PubMed  Google Scholar 

  12. 12.

    Villatte G, Engels E, Erivan R, Mulliez A, Caumon N, Boisgard S, Descamps S (2016) Effect of local anaesthetic wound infiltration on acute pain and bleeding after primary total hip arthroplasty: the EDIPO randomised controlled study. Int Orthop 40(11):2255–2260

    Article  PubMed  Google Scholar 

  13. 13.

    Reina N, Fennema P, Hourlier H (2017) The impact of mild peri-operative hypothermia on the effectiveness of tranexamic acid in total hip arthroplasty. Int Orthop 41(1):55–60. https://doi.org/10.1007/s00264-016-3170-y

    Article  PubMed  Google Scholar 

  14. 14.

    Sucher MG, Giordani M, Figoni A, Nedopil AJ (2016) Peri-operative blood-loss after total hip arthroplasty can be significantly reduced with topical application of epsilon-aminocaproic acid. Int Orthop 40(10):2019–2023

    Article  PubMed  Google Scholar 

  15. 15.

    Falez F, Meo A, Panegrossi G, Favetti F, La Cava F, Casella F (2013) Blood loss reduction in cementless total hip replacement with fibrin spray or bipolar sealer: a randomised controlled trial on ninety five patients. Int Orthop 37(7):1213–1217. https://doi.org/10.1007/s00264-013-1903-8

    Article  PubMed  PubMed Central  Google Scholar 

  16. 16.

    Andrews CM, Lane DW, Bradley JG (1997) Iron pre-load for major joint replacement. Transfus Med 7:281–286

    Article  CAS  PubMed  Google Scholar 

  17. 17.

    Lidder PG, Sanders G, Whitehead E, Douie W, Mellor N, Lewis S, Hosie K (2007) Pre-operative oral iron supplementation reduces blood transfusion in colorectal surgery - a prospective, randomised, controlled trial. Ann R Coll Surg Engl 89:418–421. https://doi.org/10.1308/003588407X183364

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  18. 18.

    Liumbruno GM, Vaglio S, Grazzini G et al (2015) Patient blood management: a fresh look at a fresh approach to blood transfusion. Minerva Anestesiol 81:1127–1137. https://doi.org/10.2450/2015.0171-15

    CAS  Article  PubMed  Google Scholar 

  19. 19.

    Meybohm P, Herrmann E, Steinbicker AU et al (2016) Patient blood management is associated with a substantial reduction of red blood cell utilization and safe for patient’s outcome: a prospective, multicenter cohort study with a noninferiority design. Ann Surg 264:203–211. https://doi.org/10.1097/SLA.0000000000001747

    Article  Google Scholar 

  20. 20.

    WHO (2011) WHO Global Forum for Blood Safety: patient blood management. http://www.who.int/bloodsafety/events/gfbs_01_pbm/en/ [Last accessed 30.04.17]

  21. 21.

    Theusinger OM, Felix C, Spahn DR (2012) Strategies to reduce the use of blood products: a European perspective. Curr Opin Anaesthesiol 25:59–65. https://doi.org/10.1097/ACO.0b013e32834dec98

    Article  CAS  PubMed  Google Scholar 

  22. 22.

    Brilli E, Romano A, Fabiano A, Zambito Y, Di Raimondo F, Tarantino G (2016) Sucrosomial® technology is able to promote ferric iron absorption: pre-clinical and clinical evidences. Blood J 128:3618

    Google Scholar 

  23. 23.

    Giordano G, Mondello P, Tambaro R et al (2015) Biosimilar epoetin α is as effective as originator epoetin-α plus liposomal iron (Sideral®), vitamin B12 and folates in patients with refractory anemia: a retrospective real-life approach. Mol Clin Oncol 3:781–784. https://doi.org/10.3892/mco.2015.555

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  24. 24.

    Locatelli F, Mazzaferro S, Yee J (2016) Iron therapy challenges for the treatment of nondialysis CKD patients. CJASN 11:1969–1980. https://doi.org/10.2215/CJN.00080116

    Article  Google Scholar 

  25. 25.

    Pisani A, Riccio E, Sabbatini M, Mi A, Del Rio A, Visciano B (2015) Effect of oral liposomal iron versus intravenous iron for treatment of iron deficiency anaemia in CKD patients: a randomized trial. Nephrol Dial Transplant 30:645–652. https://doi.org/10.1093/ndt/gfu357

    Article  CAS  PubMed  Google Scholar 

  26. 26.

    Tarantino G, Brilli E, Zambito Y et al (2015) Sucrosomial Iron®: a new highly bioavaible oral iron supplement. Blood 126:4561

    Google Scholar 

  27. 27.

    Macdougall IC (2011) Iron supplementation in nephrology and oncology: what do we have in common? Oncologist 16(Suppl 3):25–34. https://doi.org/10.1634/theoncologist.2011-S3-25

    Article  PubMed  Google Scholar 

  28. 28.

    Confalonieri N, Manzotti A, Montironi F, Pullen C (2008) Tissue sparing surgery in knee reconstruction: unicompartmental (UKA), patellofemoral (PFA), UKA + PFA, bi-unicompartmental (bi-UKA) arthroplasties. J Orthop 9:171–177. https://doi.org/10.1007/s10195-008-0015-5

    CAS  Article  Google Scholar 

  29. 29.

    Pogliacomi F, De Filippo M, Paraskevopoulos A, Alesci M, Marenghi P, Ceccarelli F (2012) Mini-incision direct lateral approach versus anterior mini-invasive approach in total hip replacement: results 1 year after surgery. Acta Biomed: Atenei Parmensis 83:114–121

    Google Scholar 

  30. 30.

    Repantis T, Bouras T, Korovessis P (2015) Comparison of minimally invasive approach versus conventional anterolateral approach for total hip arthroplasty: a randomized controlled trial. Eur J Orthop Surg Traumatol 25:111–116. https://doi.org/10.1007/s00590-014-1428-x

    Article  CAS  PubMed  Google Scholar 

  31. 31.

    Scardino M, Martorelli F, Grappiolo G (2015) Evicel and bloodless protocol in orthopaedics surgery clinical evidence and cost-analysis: Italian Experience Humanitas Research Hospital. Value Health 18:A664. https://doi.org/10.1016/j.jval.2015.09.2417

    Article  Google Scholar 

  32. 32.

    Chow SC, Shao J, Wang H (2008) Sample size calculations in clinical research, 2nd edn. Dekker, New York. https://doi.org/10.1111/j.1541-0420.2008.01138_10.x

    Book  Google Scholar 

  33. 33.

    Foss NB, Kristensen MT, Kehlet H (2008) Anaemia impedes functional mobility after hip fracture surgery. Age Ageing 37:173–178. https://doi.org/10.1093/ageing/afm161

    Article  PubMed  Google Scholar 

  34. 34.

    Lawrence VA, Silverstein JH, Cornell JE, Pederson T, Noveck H, Carson JL (2003) Higher Hb level is associated with better early functional recovery after hip fracture repair. Transfusion 43:1717–1722

    Article  PubMed  Google Scholar 

  35. 35.

    Madjdpour C, Heindl V, Spahn DR (2006) Risks, benefits, alternatives and indications of allogenic blood transfusions. Minerva Anestesiol 72:283–298. https://doi.org/10.1093/bja/aeh290

    CAS  Article  PubMed  Google Scholar 

  36. 36.

    Giordano G (2016) High dose sucrosomial iron is safe and represent a valid alternative for a quick restore of hemoglobin levels. Multicentric randomized trial. EHA, Copenhagen

    Google Scholar 

  37. 37.

    Mafodda A, Giuffrida D, Prestifilippo A, Azzarello D, Del Medico P, Mare M, Maisano R (2014) Randomized phase II trial of supplementation with oral liposomal iron versus intravenous iron in patients with chemotherapy-related anemia without Iron deficiency treated with darbepoetin alfa. Poster presented at the XVI annual conference of the Associazione Italiana Oncologia Medica (AIOM); Oct 24-26, Rome

  38. 38.

    Garrido-Martin P, Nassar-Mansur MI, de la Llana-Ducros R et al (2012) The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial. Interact Cardiovasc Thorac Surg 15:1013–1018. https://doi.org/10.1093/icvts/ivs344

    Article  PubMed  PubMed Central  Google Scholar 

  39. 39.

    ISS. Registro Italiano ArtroProtesi (RIAP) 2016 [last accessed April 7, 2017]; Available from: http://www.iss.it/riap/

  40. 40.

    Guerra R, Velati C, Liumbruno GM, Grazzini G (2016) Patient blood management in Italy. Blood Transfus 14:1–2. https://doi.org/10.2450/2015.0171-15

    Article  PubMed  PubMed Central  Google Scholar 

  41. 41.

    Jimenez-Garcia R, Villanueva-Martinez M, Fernandez-de-Las-Penas C et al (2011) Trends in primary total hip arthroplasty in Spain from 2001 to 2008: evaluating changes in demographics, comorbidity, incidence rates, length of stay, costs and mortality. BMC Musculoskelet Disord 12:43. https://doi.org/10.1186/1471-2474-12-43

    Article  PubMed  PubMed Central  Google Scholar 

  42. 42.

    Leahy M, Hofmann A, Towler S, Trentino K, Burrows S, Swain S et al (2017) Improved outcomes and reduced costs associated with a health-system–wide patient blood management program: a retrospective observational study in four major adult tertiary-care hospitals. Transfusion 57:1347–1358. https://doi.org/10.1111/trf.14006

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

The authors are grateful to Manuella Walker for assisting in drafting the manuscript.

Funding source

Financial support for language editing has been provided by PharmaNutra, Pisa, Italy, which has however not taken part in the study design, data collection or analyses, or writing of the paper.

Author information

Affiliations

Authors

Corresponding author

Correspondence to Berardo Di Matteo.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

The present study was performed in accordance with the principles outlined in the Declaration of Helsinki. Being an initiative of a pre-operative protocol standardisation established at the Orthopaedics Department, the study was presented to the local Ethics Committee of the Humanitas Research Hospital for approval and patients’ clinical data were handled as agreed by patient’s informed consent.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Scardino, M., Di Matteo, B., Martorelli, F. et al. Improved patient blood management and cost saving in hip replacement surgery through the implementation of pre-operative Sucrosomial® iron supplementation: a quality improvement assessment study. International Orthopaedics (SICOT) 43, 39–46 (2019). https://doi.org/10.1007/s00264-018-4149-7

Download citation

Keywords

  • Patient blood management
  • Peri-operatory haemoglobin levels
  • Prosthetic hip surgery
  • Sideral® Forte
  • Oral sucrosomial iron