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

April 23, 2019 updated by: Wei Wang, MD & PhD, Peking Union Medical College Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

780

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing total hip and knee arthroplasty

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
rHuEPO monotherapy group
rHuEPO was administrated during hospitalization period.
Drug: rHuEPO
rHuEPO was administrated daily with 10000 IU or 20000 IU
Other Names:
  • Recombinant Human Erythropoietin Injection
iron sucrose monotherapy group
Iron sucrose was administrated during hospitalization period.
Drug: Iron sucrose
Iron sucrose was administrated daily with 100mg or 200mg
Other Names:
  • IV iron
rHuEPO combined with iron sucrose group
rHuEPO combined with iron sucrose was administrated during hospitalization period.
Drug: rHuEPO
rHuEPO was administrated daily with 10000 IU or 20000 IU
Other Names:
  • Recombinant Human Erythropoietin Injection
Drug: Iron sucrose
Iron sucrose was administrated daily with 100mg or 200mg
Other Names:
  • IV iron
control group
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.
Time Frame: Operation day to postoperative day 7
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.
Time Frame: Operation day to postoperative day 7
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.
Time Frame: Operation day to postoperative day 7
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.
Time Frame: 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.
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.
Time Frame: 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.
Operation day to postoperative day 7
Difference in postoperative hospital days in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.
Time Frame: Up to 4 months
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.
Time Frame: Operation day to postoperative day 7
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.
Time Frame: 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.
Operation day to postoperation day 7
Differences in changes of platelet count in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.
Time Frame: Operation day to postoperative day 7
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
Time Frame: Form operation day to postoperative day 7
Adverse events and serious adverse events
Form operation day to postoperative day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Wei Wang, PhD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2019

Primary Completion (Anticipated)

May 30, 2019

Study Completion (Anticipated)

September 30, 2019

Study Registration Dates

First Submitted

April 4, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 17, 2019

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPO-retro-cohort-PUMCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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