Efficacy and Safety of Erythropoietin And/Or Intravenous Iron Sucrose For Treatment of Anemia In Hip and Knee Arthroplasty: A Single-center Retrospective Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 780
- Locations
- 1
- Primary Endpoint
- Differences in changes of Hb level in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
rHuEPO monotherapy group
rHuEPO was administrated during hospitalization period.
Intervention: rHuEPO (Drug)
iron sucrose monotherapy group
Iron sucrose was administrated during hospitalization period.
Intervention: Iron sucrose (Drug)
rHuEPO combined with iron sucrose group
rHuEPO combined with iron sucrose was administrated during hospitalization period.
Intervention: rHuEPO (Drug)
rHuEPO combined with iron sucrose group
rHuEPO combined with iron sucrose was administrated during hospitalization period.
Intervention: Iron sucrose (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Comparing differences of blood loss volume in each group.(Operation day to postoperative day 7)
- Safety of rHuEPO and/or iron sucrose(Form operation day to postoperative day 7)
- Differences in change of hematokrit (HCT) in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.(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.(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.(Operation day to postoperative day 7)
- 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)
- Difference in postoperative hospital days in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.(Up to 4 months)
- Differences in changes of platelet count in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.(Operation day to postoperative day 7)
- Comparing the rate of anemia between operation day and post-operation day 7 in each group.(Operation day to postoperation day 7)
Investigators
Wei Wang, MD & PhD
Clinical Professor
Peking Union Medical College Hospital