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

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Transfusion
• Intervention / Treatment: Drug: iron sucrose, erythropoietin-β; Drug: normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group IE; The group IE received iron sucrose and erythropoietin-β (Epo-β) during the operation	Drug: 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.; Other Names: Venoferrum; recormon
Placebo Comparator: group C; The group C received saline as same method.	Drug: normal saline; 100 ml of normal saline was given intravenously over one hour and 0.5ml was injected subcutaneously.; Other Names: sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
postoperative hemoglobin	postoperative 1, 2, 3, 5 day and 2, 6 week

Secondary Outcome Measures

Outcome Measure	Time Frame
serum iron, ferritin, total iron binding capacity (TIBC) and transferrin saturation (TSAT)	preoperation and postoperation

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Hyoseok Na, Pf, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: November 10, 2009
• First Submitted That Met QC Criteria: November 10, 2009
• First Posted (Estimate): November 11, 2009

Study Record Updates

• Last Update Posted (Estimate): August 19, 2013
• Last Update Submitted That Met QC Criteria: August 16, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: hemoglobin; erythropoietin; iron; Total knee replacement arthroplasty
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa; Ferric Oxide, Saccharated
• Other Study ID Numbers: B-0905/076-005