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Clinical Trials/NCT03917394
NCT03917394
Unknown
Not Applicable

Efficacy and Safety of Erythropoietin And/Or Intravenous Iron Sucrose For Treatment of Anemia In Hip and Knee Arthroplasty: A Single-center Retrospective Study

Peking Union Medical College Hospital1 site in 1 country780 target enrollmentApril 24, 2019

Overview

Phase
Not Applicable
Intervention
rHuEPO
Conditions
Anemia, Iron Deficiency
Sponsor
Peking Union Medical College Hospital
Enrollment
780
Locations
1
Primary Endpoint
Differences in changes of Hb level in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.
Last Updated
7 years ago

Overview

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.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
April 24, 2019
End Date
September 30, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wei Wang, MD & PhD

Clinical Professor

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

rHuEPO monotherapy group

rHuEPO was administrated during hospitalization period.

Intervention: rHuEPO

iron sucrose monotherapy group

Iron sucrose was administrated during hospitalization period.

Intervention: Iron sucrose

rHuEPO combined with iron sucrose group

rHuEPO combined with iron sucrose was administrated during hospitalization period.

Intervention: rHuEPO

rHuEPO combined with iron sucrose group

rHuEPO combined with iron sucrose was administrated during hospitalization period.

Intervention: Iron sucrose

Outcomes

Primary Outcomes

Differences in changes of Hb level in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.

Time Frame: Operation day to postoperative day 7

Changes of Hb level =Hb level in postoperative 7d - Hb level in operation day

Secondary Outcomes

  • Comparing differences of blood loss volume in each group.(Operation day to postoperative day 7)
  • Safety of rHuEPO and/or iron sucrose(Form 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)
  • 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)
  • Difference in postoperative hospital days in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.(Up to 4 months)
  • Differences in changes of platelet count in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.(Operation day to postoperative day 7)
  • Comparing the rate of anemia between operation day and post-operation day 7 in each group.(Operation day to postoperation day 7)

Study Sites (1)

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