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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01012063
First received: November 10, 2009
Last updated: August 16, 2013
Last verified: August 2013

November 10, 2009
August 16, 2013
August 2008
October 2009   (final data collection date for primary outcome measure)
postoperative hemoglobin [ Time Frame: postoperative 1, 2, 3, 5 day and 2, 6 week ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01012063 on ClinicalTrials.gov Archive Site
serum iron, ferritin, total iron binding capacity (TIBC) and transferrin saturation (TSAT) [ Time Frame: preoperation and postoperation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Perioperative Iron With Erythropoietin in Bilateral Total Knee Replacement Arthroplasty (TKRA)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Anemia
  • Transfusion
  • 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
  • Drug: normal saline
    100 ml of normal saline was given intravenously over one hour and 0.5ml was injected subcutaneously.
    Other Name: sodium chloride
  • Experimental: group IE
    The group IE received iron sucrose and erythropoietin-β (Epo-β) during the operation
    Intervention: Drug: iron sucrose, erythropoietin-β
  • Placebo Comparator: group C
    The group C received saline as same method.
    Intervention: Drug: normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Female
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01012063
B-0905/076-005
Yes
Hyo-Seok Na, Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
Not Provided
Principal Investigator: Hyoseok Na, pf Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP