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

Study 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).

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

Conditions
-----------------
Anemia, Iron Deficiency

Intervention / Treatment
-----------------
* Drug: rHuEPO
* Drug: Iron sucrose


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rHuEPO monotherapy group<br>rHuEPO was administrated during hospitalization period. | Drug: rHuEPO<br>* rHuEPO was administrated daily with 10000 IU or 20000 IU<br>* Other names: Recombinant Human Erythropoietin Injection;|
| iron sucrose monotherapy group<br>Iron sucrose was administrated during hospitalization period. | Drug: Iron sucrose<br>* Iron sucrose was administrated daily with 100mg or 200mg<br>* Other names: IV iron;|
| rHuEPO combined with iron sucrose group<br>rHuEPO combined with iron sucrose was administrated during hospitalization period. | Drug: rHuEPO<br>* rHuEPO was administrated daily with 10000 IU or 20000 IU<br>* Other names: Recombinant Human Erythropoietin Injection;Drug: Iron sucrose<br>* Iron sucrose was administrated daily with 100mg or 200mg<br>* Other names: IV iron;|
| control group<br>Subjects didn't be administrated with rHuEPO and/or iron sucrose during hospitalization period. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in change of red blood cells count(RBC) in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group. | Changes of RBC =RBC in postoperative day 7 - RBC in operation day | Operation day to postoperative day 7 | 
| Differences in change of hematokrit (HCT) in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group. | Changes of HCT =HCT level in postoperative day 7 - HCT level in operation day | 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. | 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. | 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. | 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. | Operation day to postoperative day 7 | 
| Difference in postoperative hospital days in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group. | Postoperative hospital days is defined as the number of days from operation day to hospital discharge. | Up to 4 months | 
| Comparing differences of blood loss volume in each group. | Blood loss volume is defined as the total volume of intraoperative bleeding and postoperative drainage. | Operation day to postoperative day 7 | 
| Comparing the rate of anemia between operation day and post-operation day 7 in each group. | 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. | Operation day to postoperation day 7 | 
| Differences in changes of platelet count in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group. | Changes of platelet count =platelet count in postoperative 7d - platelet count in operation day | Operation day to postoperative day 7 | 
| Safety of rHuEPO and/or iron sucrose | Adverse events and serious adverse events | Form operation day to postoperative day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
THA/TKA, Perioperative anemia, rHuEPO, iron sucrose