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

• Conditions: Anemia, Iron Deficiency
• Interventions: Drug: Iron sucrose; Drug: rHuEPO

• Registration Number: NCT03917394
• Lead Sponsor: Peking Union Medical College Hospital

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).

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-17
• Last Update Submitted: 2019-04-23
• Study Start: 2019-04-24
• Last Update Posted: 2019-04-25
• Primary Completion: 2019-05-30
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 780

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
iron sucrose monotherapy group	Iron sucrose	Iron sucrose was administrated during hospitalization period.
rHuEPO monotherapy group	rHuEPO	rHuEPO was administrated during hospitalization period.
rHuEPO combined with iron sucrose group	rHuEPO	rHuEPO combined with iron sucrose was administrated during hospitalization period.
rHuEPO combined with iron sucrose group	Iron sucrose	rHuEPO combined with iron sucrose was administrated during hospitalization period.

Primary Outcome Measures

Name	Time	Method
Differences in changes of Hb level in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.	Operation day to postoperative day 7	Changes of Hb level =Hb level in postoperative 7d - Hb level in operation day

Secondary Outcome Measures

Name	Time	Method
Comparing differences of blood loss volume in each group.	Operation day to postoperative day 7	Blood loss volume is defined as the total volume of intraoperative bleeding and postoperative drainage.
Safety of rHuEPO and/or iron sucrose	Form operation day to postoperative day 7	Adverse events and serious adverse events
Differences in change of hematokrit (HCT) in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.	Operation day to postoperative day 7	Changes of HCT =HCT level in postoperative day 7 - HCT level in operation day
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	Transfusion rate is defined as the ratio of numbers subjected to blood transfusion in each group subjects.; Blood transfusion volume is defined as the amount of blood transfusion during operation day and postoperative period.
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	Allogeneic blood transfusion volume is defined as the amount of blood transfusion volume from operation day to postoperative day 7 Blood transfusion volume is defined as the amount of blood transfusion during operation day and postoperative period.
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	Changes of RBC =RBC in postoperative day 7 - RBC in operation day
Difference in postoperative hospital days in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.	Up to 4 months	Postoperative hospital days is defined as the number of days from operation day to hospital discharge.
Differences in changes of platelet count in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.	Operation day to postoperative day 7	Changes of platelet count =platelet count in postoperative 7d - platelet count in operation day
Comparing the rate of anemia between operation day and post-operation day 7 in each group.	Operation day to postoperation day 7	According to 2011 World Health Organization(WHO) anemia standard，Hb\< 130g/L for adult men and Hb \< 120g/L for non-pregnant women are defined as anemia.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China