Perioperative Iron With Erythropoietin in Bilateral Total Knee Replacement Arthroplasty (TKRA) (SNUBH)

Seoul National University

Status: Completed

Conditions: Anemia; Transfusion

Treatments: Drug: normal saline; Drug: iron sucrose, erythropoietin-β

Study type: Interventional

Funder types: Other

Identifiers

NCT01012063

B-0905/076-005

Details and patient eligibility

About

The object of this study is to evaluate whether low dose intravenous iron and erythropoietin (Epo) can decrease transfusion requirement after the bilateral TKRA.

Full description

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.

Enrollment: 54 patients

Sex: Female

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients undergoing bilateral total knee replacement arthroplasty
• American society of anesthesiologist class 1-3
• Hb>100 g/L
• Either serum ferritin<100 ng/ml or 100<ferritin<300 ng/ml with a transferrin saturation (TSAT) <20%

Exclusion criteria

• Hematologic disease
• Thromboembolic disease
• Hepatic or renal disease
• Coagulation disorder
• Infection
• Malignancy
• Under anticoagulant therapy
• Hypersensitivity to iron sucrose or Epo
• Preoperative autologous blood donation
• Use of iron or Epo and blood transfusion within the previous 1 month

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups, including a placebo group

group IE

Experimental group

Description:

The group IE received iron sucrose and erythropoietin-β (Epo-β) during the operation

Treatment:

Drug: iron sucrose, erythropoietin-β

group C

Placebo Comparator group

Description:

The group C received saline as same method.

Treatment:

Drug: normal saline