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Completed

NCT Number: NCT01012063

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

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

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Key information

Age range

50 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iron sucrose, erythropoietin-β

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.

Other names: Venoferrum, recormon

normal saline

Drug

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

Other names: sodium chloride

Primary outcomes

  1. postoperative hemoglobin

    Time frame: postoperative 1, 2, 3, 5 day and 2, 6 week

Secondary outcomes

  1. serum iron, ferritin, total iron binding capacity (TIBC) and transferrin saturation (TSAT)

    Time frame: preoperation and postoperation

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Acronym: SNUBH

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 11, 2009
Registry last updated
Aug 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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