Perioperative Iron With Erythropoietin in Bilateral Total Knee Replacement Arthroplasty (TKRA) (SNUBH)
Primary Purpose
Anemia, Transfusion
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
iron sucrose, erythropoietin-β
normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Anemia focused on measuring iron, erythropoietin, hemoglobin, Total knee replacement arthroplasty
Eligibility 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
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
group IE
group C
Arm Description
The group IE received iron sucrose and erythropoietin-β (Epo-β) during the operation
The group C received saline as same method.
Outcomes
Primary Outcome Measures
postoperative hemoglobin
Secondary Outcome Measures
serum iron, ferritin, total iron binding capacity (TIBC) and transferrin saturation (TSAT)
Full Information
NCT ID
NCT01012063
First Posted
November 10, 2009
Last Updated
August 16, 2013
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01012063
Brief Title
Perioperative Iron With Erythropoietin in Bilateral Total Knee Replacement Arthroplasty (TKRA)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Transfusion
Keywords
iron, erythropoietin, hemoglobin, Total knee replacement arthroplasty
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group IE
Arm Type
Experimental
Arm Description
The group IE received iron sucrose and erythropoietin-β (Epo-β) during the operation
Arm Title
group C
Arm Type
Placebo Comparator
Arm Description
The group C received saline as same method.
Intervention Type
Drug
Intervention Name(s)
iron sucrose, erythropoietin-β
Other Intervention Name(s)
Venoferrum, recormon
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
sodium chloride
Intervention Description
100 ml of normal saline was given intravenously over one hour and 0.5ml was injected subcutaneously.
Primary Outcome Measure Information:
Title
postoperative hemoglobin
Time Frame
postoperative 1, 2, 3, 5 day and 2, 6 week
Secondary Outcome Measure Information:
Title
serum iron, ferritin, total iron binding capacity (TIBC) and transferrin saturation (TSAT)
Time Frame
preoperation and postoperation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyoseok Na, pf
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
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Perioperative Iron With Erythropoietin in Bilateral Total Knee Replacement Arthroplasty (TKRA)
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