Erythropoietin And/Or Iron Sucrose For Perioperative Anemia Management In Hip and Knee Arthroplasty
Efficacy and Safety of Erythropoietin And/Or Intravenous Iron Sucrose For Treatment of Anemia In Hip and Knee Arthroplasty: A Single-center Retrospective Study
1 other identifier
observational
780
1 country
1
Brief Summary
Perioperative anemia is very common in patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA). This study retrospectively analyzes the use of rHuEPO and iron sucrose in patients undergoing total hip and knee arthroplasty in order to observe the short-term efficacy and safety of rHuEPO and iron sucrose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 17, 2019
CompletedStudy Start
First participant enrolled
April 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedApril 25, 2019
April 1, 2019
1 month
April 4, 2019
April 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Differences in changes of Hb level in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.
Changes of Hb level =Hb level in postoperative 7d - Hb level in operation day
Operation day to postoperative day 7
Secondary Outcomes (9)
Differences in change of red blood cells count(RBC) in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.
Operation day to postoperative day 7
Differences in change of hematokrit (HCT) in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.
Operation day to postoperative day 7
Differences in change of allogeneic transfusion rate(%) in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.
Operation day to postoperative day 7
Differences in change of allogeneic blood transfusion volume in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.
Operation day to postoperative day 7
Difference in postoperative hospital days in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.
Up to 4 months
- +4 more secondary outcomes
Study Arms (4)
rHuEPO monotherapy group
rHuEPO was administrated during hospitalization period.
iron sucrose monotherapy group
Iron sucrose was administrated during hospitalization period.
rHuEPO combined with iron sucrose group
rHuEPO combined with iron sucrose was administrated during hospitalization period.
control group
Subjects didn't be administrated with rHuEPO and/or iron sucrose during hospitalization period.
Interventions
rHuEPO was administrated daily with 10000 IU or 20000 IU
Iron sucrose was administrated daily with 100mg or 200mg
Eligibility Criteria
Patients undergoing total hip and knee arthroplasty
You may qualify if:
- Patients who underwent hip or knee arthroplasty between May 1, 2012 (included) and December 31, 2015 in Peking Union Medical College Hospital
- Age ≥ 18 years, sex unlimited
You may not qualify if:
- Patients with serious absence of clinical data
- Patients with rHuEPO contraindication
- Patients with uncontrolled severe hypertension
- Patients allergic to this product and other mammalian cell derivatives, or to human serum albumin
- Co-infected patients
- Patients definitely allergic to iron sucrose injection
- Patients with coagulation dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (12)
Watts CD, Pagnano MW. Minimising blood loss and transfusion in contemporary hip and knee arthroplasty. J Bone Joint Surg Br. 2012 Nov;94(11 Suppl A):8-10. doi: 10.1302/0301-620X.94B11.30618.
PMID: 23118371BACKGROUNDNa HS, Shin SY, Hwang JY, Jeon YT, Kim CS, Do SH. Effects of intravenous iron combined with low-dose recombinant human erythropoietin on transfusion requirements in iron-deficient patients undergoing bilateral total knee replacement arthroplasty. Transfusion. 2011 Jan;51(1):118-24. doi: 10.1111/j.1537-2995.2010.02783.x.
PMID: 20624257BACKGROUNDConlon NP, Bale EP, Herbison GP, McCarroll M. Postoperative anemia and quality of life after primary hip arthroplasty in patients over 65 years old. Anesth Analg. 2008 Apr;106(4):1056-61, table of contents. doi: 10.1213/ane.0b013e318164f114.
PMID: 18349173BACKGROUNDBou Monsef J, Boettner F. Blood management may have an impact on length of stay after total hip arthroplasty. HSS J. 2014 Jul;10(2):124-30. doi: 10.1007/s11420-014-9384-x. Epub 2014 Apr 8.
PMID: 25050095BACKGROUNDLin DM, Lin ES, Tran MH. Efficacy and safety of erythropoietin and intravenous iron in perioperative blood management: a systematic review. Transfus Med Rev. 2013 Oct;27(4):221-34. doi: 10.1016/j.tmrv.2013.09.001. Epub 2013 Oct 15.
PMID: 24135037BACKGROUNDVoorn VM, van der Hout A, So-Osman C, Vliet Vlieland TP, Nelissen RG, van den Akker-van Marle ME, Dahan A, Marang-van de Mheen PJ, van Bodegom-Vos L. Erythropoietin to reduce allogeneic red blood cell transfusion in patients undergoing total hip or knee arthroplasty. Vox Sang. 2016 Oct;111(3):219-225. doi: 10.1111/vox.12412. Epub 2016 Jun 17.
PMID: 27314459BACKGROUNDTran DH, Wong GT, Chee YE, Irwin MG. Effectiveness and safety of erythropoiesis-stimulating agent use in the perioperative period. Expert Opin Biol Ther. 2014 Jan;14(1):51-61. doi: 10.1517/14712598.2014.858116. Epub 2013 Nov 13.
PMID: 24219367BACKGROUNDLi Y, Yin P, Lv H, Meng Y, Zhang L, Tang P. A meta-analysis and systematic review evaluating the use of erythropoietin in total hip and knee arthroplasty. Ther Clin Risk Manag. 2018 Jul 10;14:1191-1204. doi: 10.2147/TCRM.S159134. eCollection 2018.
PMID: 30022832BACKGROUNDCrosby E. Perioperative use of erythropoietin. Am J Ther. 2002 Sep-Oct;9(5):371-6. doi: 10.1097/00045391-200209000-00003.
PMID: 12237728BACKGROUNDClevenger B, Richards T. Pre-operative anaemia. Anaesthesia. 2015 Jan;70 Suppl 1:20-8, e6-8. doi: 10.1111/anae.12918.
PMID: 25440391BACKGROUNDMunoz M, Acheson AG, Auerbach M, Besser M, Habler O, Kehlet H, Liumbruno GM, Lasocki S, Meybohm P, Rao Baikady R, Richards T, Shander A, So-Osman C, Spahn DR, Klein AA. International consensus statement on the peri-operative management of anaemia and iron deficiency. Anaesthesia. 2017 Feb;72(2):233-247. doi: 10.1111/anae.13773. Epub 2016 Dec 20.
PMID: 27996086BACKGROUNDMunoz M, Gomez-Ramirez S, Cuenca J, Garcia-Erce JA, Iglesias-Aparicio D, Haman-Alcober S, Ariza D, Naveira E. Very-short-term perioperative intravenous iron administration and postoperative outcome in major orthopedic surgery: a pooled analysis of observational data from 2547 patients. Transfusion. 2014 Feb;54(2):289-99. doi: 10.1111/trf.12195. Epub 2013 Apr 15.
PMID: 23581484BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Wang, PhD
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
April 4, 2019
First Posted
April 17, 2019
Study Start
April 24, 2019
Primary Completion
May 30, 2019
Study Completion
September 30, 2019
Last Updated
April 25, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share