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

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ClinicalTrials.gov Identifier: NCT03917394
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Wei Wang, MD & PhD, 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.

Condition or disease Intervention/treatment
Anemia, Iron Deficiency Drug: rHuEPO Drug: 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).

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Study Type : Observational
Estimated Enrollment : 780 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Recombinant Human Erythropoietin Injection

Drug: Iron sucrose
Iron sucrose was administrated daily with 100mg or 200mg
Other Name: IV iron

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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.


  4. 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.

  5. 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.

  6. 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.

  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.

  8. 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

  9. Safety of rHuEPO and/or iron sucrose [ Time Frame: Form operation day to postoperative day 7 ]
    Adverse events and serious adverse events



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing total hip and knee arthroplasty
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917394


Contacts
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Contact: Wei Wang, PhD 86-18612672533 wangwei4531@pumch.cn
Contact: Rui Wang, Master 86-13918856408 fdwangrui@126.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Wei Wang, PhD    86-18612672533    wangwei4531@pumch.cn   
Contact: Rui Wang, Master    86-13918856408    fdwangrui@126.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Wei Wang, PhD Peking Union Medical College Hospital

Publications:

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Responsible Party: Wei Wang, MD & PhD, Clinical Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03917394     History of Changes
Other Study ID Numbers: EPO-retro-cohort-PUMCH
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wei Wang, MD & PhD, Peking Union Medical College Hospital:
THA/TKA
Perioperative anemia
rHuEPO
iron sucrose

Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Epoetin Alfa
Ferric Oxide, Saccharated
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics