Anemia, Iron Deficiency
Conditions
Keywords
THA/TKA, Perioperative anemia, rHuEPO, iron sucrose
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).
Interventions
DRUGrHuEPO
rHuEPO was administrated daily with 10000 IU or 20000 IU
DRUGIron sucrose
Iron sucrose was administrated daily with 100mg or 200mg
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in changes of Hb level in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group. | Operation day to postoperative day 7 | Changes of Hb level =Hb level in postoperative 7d - Hb level in operation day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in change of hematokrit (HCT) in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group. | Operation day to postoperative day 7 | Changes of HCT =HCT level in postoperative day 7 - HCT level in operation day |
| 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 | 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. |
| 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 | 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. |
| Difference in postoperative hospital days in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group. | Up to 4 months | Postoperative hospital days is defined as the number of days from operation day to hospital discharge. |
| 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 | Changes of RBC =RBC in postoperative day 7 - RBC in operation day |
| Comparing the rate of anemia between operation day and post-operation day 7 in each group. | 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. |
| Differences in changes of platelet count in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group. | Operation day to postoperative day 7 | Changes of platelet count =platelet count in postoperative 7d - platelet count in operation day |
| Safety of rHuEPO and/or iron sucrose | Form operation day to postoperative day 7 | Adverse events and serious adverse events |
| Comparing differences of blood loss volume in each group. | Operation day to postoperative day 7 | Blood loss volume is defined as the total volume of intraoperative bleeding and postoperative drainage. |
Countries
China
Contacts
Primary ContactWei Wang, PhD
Backup ContactRui Wang, Master
Outcome results
None listed