AnemiaSNUBHNCT01012063
Perioperative Iron With Erythropoietin in Bilateral Total Knee Replacement Arthroplasty (TKRA)
A study testing iron sucrose, erythropoietin-β and normal saline in people with Anemia and Transfusion, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Anemia, Transfusion
- What is being tested?
- iron sucrose, erythropoietin-β and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2008to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- Hematologic disease
- Thromboembolic disease
- Hepatic or renal disease
- Coagulation disorder
- Infection
- Malignancy
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: 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.
Read the 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.
- Conditions
- Anemia, Transfusion
- Being tested
- iron sucrose, erythropoietin-β, normal saline
- Keywords
- iron, erythropoietin, hemoglobin, Total knee replacement arthroplasty
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron sucrose, erythropoietin-βDrug
Also called Venoferrum, recormon
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.
normal salineDrug
Also called sodium chloride
100 ml of normal saline was given intravenously over one hour and 0.5ml was injected subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| group IE | Experimental | The group IE received iron sucrose and erythropoietin-β (Epo-β) during the operation Receives: Drug: iron sucrose, erythropoietin-β |
| group C | Placebo comparator | The group C received saline as same method. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative hemoglobin
Measured: 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)
Measured: preoperation and postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startAug 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
- Investigators
- Hyoseok Na, pf, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012063
- Sponsor's protocol ID
- B-0905/076-005
- Acronym
- SNUBH
- Status last verified
- Aug 2013
- First submitted
- 10 Nov 2009
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Intravenous Iron With Erythropoietin for the Prevention of Postoperative Severe Anemia and Reduction of Transfusion in Bilateral Total Knee Replacement Arthroplasty
- ClinicalTrials.gov ID
- NCT01012063
- Acronym / sponsor ID
- SNUBH / B-0905/076-005
- Conditions
- Anemia, Transfusion
- Keywords
- iron, erythropoietin, hemoglobin, Total knee replacement arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group IE | Experimental | Drug: iron sucrose, erythropoietin-βThe group IE received iron sucrose and erythropoietin-β (Epo-β) during the operation |
| group C | Placebo comparator | Drug: normal salineThe group C received saline as same method. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (10 listed)
- Hematologic disease
- Thromboembolic disease
- Hepatic or renal disease
- Coagulation disorder
- Infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iron sucrose, erythropoietin-βAlso: Venoferrum, recormonThe 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. | Drug | group IE |
| normal salineAlso: sodium chloride100 ml of normal saline was given intravenously over one hour and 0.5ml was injected subcutaneously. | Drug | group C |
Primary outcome
postoperative hemoglobin
Time frame: postoperative 1, 2, 3, 5 day and 2, 6 week
1 secondary outcome
serum iron, ferritin, total iron binding capacity (TIBC) and transferrin saturation (TSAT)
Time frame: preoperation and postoperation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyoseok Na, pf principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iron sucrose, erythropoietin-β and normal saline in people with Anemia and Transfusion, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative hemoglobin (time frame: postoperative 1, 2, 3, 5 day and 2, 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2013.