Anemia Clinical Trial
Official title:
Perioperative Intravenous Iron With Erythropoietin for the Prevention of Postoperative Severe Anemia and Reduction of Transfusion in Bilateral Total Knee Replacement Arthroplasty
The object of this study is to evaluate whether low dose intravenous iron and erythropoietin (Epo) can decrease transfusion requirement after the bilateral TKRA.
Total knee replacement arthroplasty (TKRA) in severe osteoarthritis usually requires
extensive soft tissue and bone dissection associated with substantial bleeding. Because TKRA
is performed with a pneumatic tourniquet, intraoperative bleeding is not substantial,
however, over 80% of the total blood loss occurs within the first 24 hour after the
operation and the hidden blood loss is 50% of the total loss, making the true blood loss
twice. Consequently, many patients can become anemic at early postoperative period and this
anemic condition may lead to overall physical deterioration which include fatigue,
dizziness, reduced exercise tolerance and delayed recovery.
Therefore, many patients frequently received the autologous or allogenic blood transfusion.
In order to reduce the allogenic blood transfusion (ABT), various methods have been used,
such as preoperative autologous blood donation (PABD), use of pharmacologic agents, iron or
erythropoietin (Epo) and postoperative blood salvage. All of the above methods have been
proved to reduce the ABT effectively6, without increase in cost.
Iron and Epo have been used widely in a variety of clinical situations instead of allogenic
RBC transfusion. They also have been used for augmenting PABD or improving preoperative
hemoglobin (Hb) level. However, there still remains a controversy about the efficacy of the
method on the postoperative anemia. We think that these various results may be related with
individual iron state of the patients and dose of drug or timing of drug application.
In this trial, iron and Epo are planned to be administered to the iron deficient non anemic
patients during the operation and once again after surgery.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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