Anemia, Iron DeficiencyNCT03917394
Erythropoietin And/Or Iron Sucrose For Perioperative Anemia Management In Hip and Knee Arthroplasty
An observational study of Anemia, Iron Deficiency, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anemia, Iron Deficiency
- What is being tested?
- rHuEPO and Iron sucrose
- Type of treatment
- Injection or infusion
- How many people
- 780 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing total hip and knee arthroplasty
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Wei Wang, PhD, 86-18612672533, wangwei4531@pumch.cn
Rui Wang, Master, 86-13918856408, fdwangrui@126.com
About this study
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
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.
Read the 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).
- Conditions
- Anemia, Iron Deficiency
- Being tested
- rHuEPO, Iron sucrose
- Keywords
- THA/TKA, Perioperative anemia, rHuEPO, iron sucrose
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rHuEPODrug
Also called Recombinant Human Erythropoietin Injection
rHuEPO was administrated daily with 10000 IU or 20000 IU
Iron sucroseDrug
Also called IV iron
Iron sucrose was administrated daily with 100mg or 200mg
| Study group | Role | What they receive |
|---|---|---|
| rHuEPO monotherapy group | rHuEPO was administrated during hospitalization period. Receives: Drug: rHuEPO | |
| iron sucrose monotherapy group | Iron sucrose was administrated during hospitalization period. Receives: Drug: Iron sucrose | |
| rHuEPO combined with iron sucrose group | rHuEPO combined with iron sucrose was administrated during hospitalization period. Receives: Drug: rHuEPO; Drug: Iron sucrose | |
| control group | Subjects didn't be administrated with rHuEPO and/or iron sucrose during hospitalization period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Operation day to postoperative day 7
Secondary outcomes (9)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Operation day to postoperative day 7
Safety of rHuEPO and/or iron sucrose
Adverse events and serious adverse events
Measured: Form operation day to postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start24 Apr 2019
- Primary completion30 May 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Wang, MD & PhD, Peking Union Medical College Hospital
- Investigators
- Wei Wang, PhD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917394
- Sponsor's protocol ID
- EPO-retro-cohort-PUMCH
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2019
- Last updated
- 25 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Watts CD, Pagnano MW. Minimising blood loss and transfusion in contemporary hip and knee arthroplasty. J Bone Joint Surg Br. 2012 Nov;94(11 Suppl A):8-10. doi: 10.1302/0301-620X.94B11.30618.
PubMed 23118371Na HS, Shin SY, Hwang JY, Jeon YT, Kim CS, Do SH. Effects of intravenous iron combined with low-dose recombinant human erythropoietin on transfusion requirements in iron-deficient patients undergoing bilateral total knee replacement arthroplasty. Transfusion. 2011 Jan;51(1):118-24. doi: 10.1111/j.1537-2995.2010.02783.x.
PubMed 20624257Conlon NP, Bale EP, Herbison GP, McCarroll M. Postoperative anemia and quality of life after primary hip arthroplasty in patients over 65 years old. Anesth Analg. 2008 Apr;106(4):1056-61, table of contents. doi: 10.1213/ane.0b013e318164f114.
PubMed 18349173Bou Monsef J, Boettner F. Blood management may have an impact on length of stay after total hip arthroplasty. HSS J. 2014 Jul;10(2):124-30. doi: 10.1007/s11420-014-9384-x. Epub 2014 Apr 8.
PubMed 25050095Lin DM, Lin ES, Tran MH. Efficacy and safety of erythropoietin and intravenous iron in perioperative blood management: a systematic review. Transfus Med Rev. 2013 Oct;27(4):221-34. doi: 10.1016/j.tmrv.2013.09.001. Epub 2013 Oct 15.
PubMed 24135037Voorn VM, van der Hout A, So-Osman C, Vliet Vlieland TP, Nelissen RG, van den Akker-van Marle ME, Dahan A, Marang-van de Mheen PJ, van Bodegom-Vos L. Erythropoietin to reduce allogeneic red blood cell transfusion in patients undergoing total hip or knee arthroplasty. Vox Sang. 2016 Oct;111(3):219-225. doi: 10.1111/vox.12412. Epub 2016 Jun 17.
PubMed 27314459Tran DH, Wong GT, Chee YE, Irwin MG. Effectiveness and safety of erythropoiesis-stimulating agent use in the perioperative period. Expert Opin Biol Ther. 2014 Jan;14(1):51-61. doi: 10.1517/14712598.2014.858116. Epub 2013 Nov 13.
PubMed 24219367Li Y, Yin P, Lv H, Meng Y, Zhang L, Tang P. A meta-analysis and systematic review evaluating the use of erythropoietin in total hip and knee arthroplasty. Ther Clin Risk Manag. 2018 Jul 10;14:1191-1204. doi: 10.2147/TCRM.S159134. eCollection 2018.
PubMed 30022832Crosby E. Perioperative use of erythropoietin. Am J Ther. 2002 Sep-Oct;9(5):371-6. doi: 10.1097/00045391-200209000-00003.
PubMed 12237728Clevenger B, Richards T. Pre-operative anaemia. Anaesthesia. 2015 Jan;70 Suppl 1:20-8, e6-8. doi: 10.1111/anae.12918.
PubMed 25440391Munoz M, Acheson AG, Auerbach M, Besser M, Habler O, Kehlet H, Liumbruno GM, Lasocki S, Meybohm P, Rao Baikady R, Richards T, Shander A, So-Osman C, Spahn DR, Klein AA. International consensus statement on the peri-operative management of anaemia and iron deficiency. Anaesthesia. 2017 Feb;72(2):233-247. doi: 10.1111/anae.13773. Epub 2016 Dec 20.
PubMed 27996086Munoz M, Gomez-Ramirez S, Cuenca J, Garcia-Erce JA, Iglesias-Aparicio D, Haman-Alcober S, Ariza D, Naveira E. Very-short-term perioperative intravenous iron administration and postoperative outcome in major orthopedic surgery: a pooled analysis of observational data from 2547 patients. Transfusion. 2014 Feb;54(2):289-99. doi: 10.1111/trf.12195. Epub 2013 Apr 15.
PubMed 23581484
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03917394
- Acronym / sponsor ID
- EPO-retro-cohort-PUMCH
- Conditions
- Anemia, Iron Deficiency
- Keywords
- THA/TKA, Perioperative anemia, rHuEPO, iron sucrose
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| rHuEPO monotherapy group | – | Drug: rHuEPOrHuEPO was administrated during hospitalization period. |
| iron sucrose monotherapy group | – | Drug: Iron sucroseIron sucrose was administrated during hospitalization period. |
| rHuEPO combined with iron sucrose group | – | Drug: rHuEPO, Drug: Iron sucroserHuEPO combined with iron sucrose was administrated during hospitalization period. |
| control group | – | –Subjects didn't be administrated with rHuEPO and/or iron sucrose during hospitalization period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing total hip and knee arthroplasty
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- Patients with serious absence of clinical data
- Patients with rHuEPO contraindication
- Patients definitely allergic to iron sucrose injection
- Patients with coagulation dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rHuEPOAlso: Recombinant Human Erythropoietin InjectionrHuEPO was administrated daily with 10000 IU or 20000 IU | Drug | rHuEPO combined with iron sucrose group, rHuEPO monotherapy group |
| Iron sucroseAlso: IV ironIron sucrose was administrated daily with 100mg or 200mg | Drug | iron sucrose monotherapy group, rHuEPO combined with iron sucrose group |
Primary outcome
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
9 secondary outcomes
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
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
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
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
Difference in postoperative hospital days in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.
Time frame: Up to 4 months
Comparing differences of blood loss volume in each group.
Time frame: 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
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
Safety of rHuEPO and/or iron sucrose
Time frame: Form operation day to postoperative day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Background: PubMed 23118371Watts CD, Pagnano MW. Minimising blood loss and transfusion in contemporary hip and knee arthroplasty. J Bone Joint Surg Br. 2012 Nov;94(11 Suppl A):8-10. doi: 10.1302/0301-620X.94B11.30618.
- Background: PubMed 20624257Na HS, Shin SY, Hwang JY, Jeon YT, Kim CS, Do SH. Effects of intravenous iron combined with low-dose recombinant human erythropoietin on transfusion requirements in iron-deficient patients undergoing bilateral total knee replacement arthroplasty. Transfusion. 2011 Jan;51(1):118-24. doi: 10.1111/j.1537-2995.2010.02783.x.
- Background: PubMed 18349173Conlon NP, Bale EP, Herbison GP, McCarroll M. Postoperative anemia and quality of life after primary hip arthroplasty in patients over 65 years old. Anesth Analg. 2008 Apr;106(4):1056-61, table of contents. doi: 10.1213/ane.0b013e318164f114.
- Background: PubMed 25050095Bou Monsef J, Boettner F. Blood management may have an impact on length of stay after total hip arthroplasty. HSS J. 2014 Jul;10(2):124-30. doi: 10.1007/s11420-014-9384-x. Epub 2014 Apr 8.
- Background: PubMed 24135037Lin DM, Lin ES, Tran MH. Efficacy and safety of erythropoietin and intravenous iron in perioperative blood management: a systematic review. Transfus Med Rev. 2013 Oct;27(4):221-34. doi: 10.1016/j.tmrv.2013.09.001. Epub 2013 Oct 15.
- Background: PubMed 27314459Voorn VM, van der Hout A, So-Osman C, Vliet Vlieland TP, Nelissen RG, van den Akker-van Marle ME, Dahan A, Marang-van de Mheen PJ, van Bodegom-Vos L. Erythropoietin to reduce allogeneic red blood cell transfusion in patients undergoing total hip or knee arthroplasty. Vox Sang. 2016 Oct;111(3):219-225. doi: 10.1111/vox.12412. Epub 2016 Jun 17.
- Background: PubMed 24219367Tran DH, Wong GT, Chee YE, Irwin MG. Effectiveness and safety of erythropoiesis-stimulating agent use in the perioperative period. Expert Opin Biol Ther. 2014 Jan;14(1):51-61. doi: 10.1517/14712598.2014.858116. Epub 2013 Nov 13.
- Background: PubMed 30022832Li Y, Yin P, Lv H, Meng Y, Zhang L, Tang P. A meta-analysis and systematic review evaluating the use of erythropoietin in total hip and knee arthroplasty. Ther Clin Risk Manag. 2018 Jul 10;14:1191-1204. doi: 10.2147/TCRM.S159134. eCollection 2018.
- Background: PubMed 12237728Crosby E. Perioperative use of erythropoietin. Am J Ther. 2002 Sep-Oct;9(5):371-6. doi: 10.1097/00045391-200209000-00003.
- Background: PubMed 25440391Clevenger B, Richards T. Pre-operative anaemia. Anaesthesia. 2015 Jan;70 Suppl 1:20-8, e6-8. doi: 10.1111/anae.12918.
- Background: PubMed 27996086Munoz M, Acheson AG, Auerbach M, Besser M, Habler O, Kehlet H, Liumbruno GM, Lasocki S, Meybohm P, Rao Baikady R, Richards T, Shander A, So-Osman C, Spahn DR, Klein AA. International consensus statement on the peri-operative management of anaemia and iron deficiency. Anaesthesia. 2017 Feb;72(2):233-247. doi: 10.1111/anae.13773. Epub 2016 Dec 20.
- Background: PubMed 23581484Munoz M, Gomez-Ramirez S, Cuenca J, Garcia-Erce JA, Iglesias-Aparicio D, Haman-Alcober S, Ariza D, Naveira E. Very-short-term perioperative intravenous iron administration and postoperative outcome in major orthopedic surgery: a pooled analysis of observational data from 2547 patients. Transfusion. 2014 Feb;54(2):289-99. doi: 10.1111/trf.12195. Epub 2013 Apr 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Wang, PhD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, Iron Deficiency, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Wang, PhD (86-18612672533, wangwei4531@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03917394, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.