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

NCT ID: NCT01012063

Last Updated: 2013-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-10-31

Brief Summary

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

Detailed 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.

Conditions

Anemia; Transfusion

Keywords

iron; erythropoietin; hemoglobin; Total knee replacement arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

group IE

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

Group Type: EXPERIMENTAL

iron sucrose, erythropoietin-β

Intervention Type: DRUG

The 200 mg of iron sucrose diluted with 100 ml of normal saline was given intravenously over one hour and the 3000 IU of Epo-β was injected subcutaneously.

group C

The group C received saline as same method.

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

100 ml of normal saline was given intravenously over one hour and 0.5ml was injected subcutaneously.

Interventions

iron sucrose, erythropoietin-β

The 200 mg of iron sucrose diluted with 100 ml of normal saline was given intravenously over one hour and the 3000 IU of Epo-β was injected subcutaneously.

Intervention Type: DRUG

normal saline

100 ml of normal saline was given intravenously over one hour and 0.5ml was injected subcutaneously.

Intervention Type: DRUG

Other Intervention Names

Venoferrum; recormon; sodium chloride

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hyo-Seok Na

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyoseok Na, pf

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

B-0905/076-005

Identifier Type: -

Identifier Source: org_study_id