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

Anemia Clinical Trial

— SNUBH  

Official title:

Perioperative Intravenous Iron With Erythropoietin for the Prevention of Postoperative Severe Anemia and Reduction of Transfusion in Bilateral Total Knee Replacement Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012063
• Other study ID #: B-0905/076-005
• Status: Completed
• Phase: N/A
• First received: November 10, 2009
• Last updated: August 16, 2013
• Start date: August 2008
• Est. completion date: October 2009

Study information

• Verified date: August 2013
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Transfusion

Intervention

Drug:
• iron sucrose, erythropoietin-ß
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-ß was injected subcutaneously.
• normal saline
100 ml of normal saline was given intravenously over one hour and 0.5ml was injected subcutaneously.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative hemoglobin		postoperative 1, 2, 3, 5 day and 2, 6 week	Yes
Secondary	serum iron, ferritin, total iron binding capacity (TIBC) and transferrin saturation (TSAT)		preoperation and postoperation	Yes