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
  Purpose

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


Condition Intervention
Anemia
Transfusion
Drug: iron sucrose, erythropoietin-β
Drug: normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Perioperative Intravenous Iron With Erythropoietin for the Prevention of Postoperative Severe Anemia and Reduction of Transfusion in Bilateral Total Knee Replacement Arthroplasty

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • postoperative hemoglobin [ Time Frame: postoperative 1, 2, 3, 5 day and 2, 6 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • serum iron, ferritin, total iron binding capacity (TIBC) and transferrin saturation (TSAT) [ Time Frame: preoperation and postoperation ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: August 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: sodium chloride

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012063

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Hyoseok Na, pf Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Hyo-Seok Na, Dr., Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01012063     History of Changes
Other Study ID Numbers: B-0905/076-005
Study First Received: November 10, 2009
Last Updated: August 16, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
iron
erythropoietin
hemoglobin
Total knee replacement arthroplasty

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Ferric oxide, saccharated
Epoetin Alfa
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014