Erythropoietin And/Or Iron Sucrose For Perioperative Anemia Management In Hip and Knee Arthroplasty

NCT ID: NCT03917394

Last Updated: 2019-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

780 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-24

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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This study aims to explore whether short-term use of rHuEPO and iron sucrose can improve postoperative anemia and promote postoperative rehabilitation after hip and knee arthroplasty. According to different therapies of perioperative anemia , included subjects would be divided into rHuEPO monotherapy group, iron sucrose monotherapy group, rHuEPO combined with iron sucrose group and control group (without rHuEPO and iron sucrose).

Conditions

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Anemia, Iron Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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rHuEPO monotherapy group

rHuEPO was administrated during hospitalization period.

rHuEPO

Intervention Type DRUG

rHuEPO was administrated daily with 10000 IU or 20000 IU

iron sucrose monotherapy group

Iron sucrose was administrated during hospitalization period.

Iron sucrose

Intervention Type DRUG

Iron sucrose was administrated daily with 100mg or 200mg

rHuEPO combined with iron sucrose group

rHuEPO combined with iron sucrose was administrated during hospitalization period.

rHuEPO

Intervention Type DRUG

rHuEPO was administrated daily with 10000 IU or 20000 IU

Iron sucrose

Intervention Type DRUG

Iron sucrose was administrated daily with 100mg or 200mg

control group

Subjects didn't be administrated with rHuEPO and/or iron sucrose during hospitalization period.

No interventions assigned to this group

Interventions

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rHuEPO

rHuEPO was administrated daily with 10000 IU or 20000 IU

Intervention Type DRUG

Iron sucrose

Iron sucrose was administrated daily with 100mg or 200mg

Intervention Type DRUG

Other Intervention Names

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Recombinant Human Erythropoietin Injection IV iron

Eligibility Criteria

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Inclusion Criteria

1. Patients who underwent hip or knee arthroplasty between May 1, 2012 (included) and December 31, 2015 in Peking Union Medical College Hospital
2. Age ≥ 18 years, sex unlimited

Exclusion Criteria

1. Patients with serious absence of clinical data
2. Patients with rHuEPO contraindication

1. Patients with uncontrolled severe hypertension
2. Patients allergic to this product and other mammalian cell derivatives, or to human serum albumin
3. Co-infected patients
3. Patients definitely allergic to iron sucrose injection
4. Patients with coagulation dysfunction
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wei Wang, MD & PhD

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Wang, PhD

Role: CONTACT

86-18612672533

Rui Wang, Master

Role: CONTACT

86-13918856408

Facility Contacts

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Wei Wang, PhD

Role: primary

86-18612672533

Rui Wang, Master

Role: backup

86-13918856408

References

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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.

Reference Type BACKGROUND
PMID: 23118371 (View on PubMed)

Na 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.

Reference Type BACKGROUND
PMID: 20624257 (View on PubMed)

Conlon 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.

Reference Type BACKGROUND
PMID: 18349173 (View on PubMed)

Bou 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.

Reference Type BACKGROUND
PMID: 25050095 (View on PubMed)

Lin 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.

Reference Type BACKGROUND
PMID: 24135037 (View on PubMed)

Voorn 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.

Reference Type BACKGROUND
PMID: 27314459 (View on PubMed)

Tran 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.

Reference Type BACKGROUND
PMID: 24219367 (View on PubMed)

Li 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.

Reference Type BACKGROUND
PMID: 30022832 (View on PubMed)

Crosby E. Perioperative use of erythropoietin. Am J Ther. 2002 Sep-Oct;9(5):371-6. doi: 10.1097/00045391-200209000-00003.

Reference Type BACKGROUND
PMID: 12237728 (View on PubMed)

Clevenger B, Richards T. Pre-operative anaemia. Anaesthesia. 2015 Jan;70 Suppl 1:20-8, e6-8. doi: 10.1111/anae.12918.

Reference Type BACKGROUND
PMID: 25440391 (View on PubMed)

Munoz 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.

Reference Type BACKGROUND
PMID: 27996086 (View on PubMed)

Munoz 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.

Reference Type BACKGROUND
PMID: 23581484 (View on PubMed)

Other Identifiers

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EPO-retro-cohort-PUMCH

Identifier Type: -

Identifier Source: org_study_id

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