AnemiaNCT03470649
Effect of IV Iron Isomaltoside on Postoperative Anemia in Total Knee Arthroplasty Patients
A study testing Iron Isomaltoside 1000 in people with Anemia and Knee Arthropathy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Postoperative anemia is a frequent complication after total knee arthroplasty, with an incidence of 87%. Iron supplementation is known to be effective in treatment and prevention of postoperative anemia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anemia, Knee Arthropathy
- What is being tested?
- Iron Isomaltoside 1000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Mar 2018to 17 Apr 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing total knee arthroplasty
Who cannot join
- bilateral total knee arthroplasty
- hematochromatosis or hemosiderosis
- hemolytic anemia
- history of drug allergy
- liver cirrhosis or hepatitis
- systematic lupus erythematosus
Show all 10Show fewer
- rheumatic arthritis
- allergic disease
- history of transfusion within one month from surgery
- parturient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Iron Isomaltoside on Postoperative Anemia in Patients Underwent Total Knee Arthroplasty: A Single-blind Randomized Controlled Trial
Postoperative anemia is a frequent complication after total knee arthroplasty, with an incidence of 87%. Iron supplementation is known to be effective in treatment and prevention of postoperative anemia. The investigators examined the effect of intravenous iron isomaltoside (Monofer®) administration on postoperative anemia and transfusion requirements in patients undergoing total knee arthroplasty.
Participants undergoing total knee arthroplasty will be randomly assigned to treatment group or control group. After main procedure of total knee arthroplasty, iron isomaltoside 1000 (Monofer®) or normal saline will be intravenously administered depending on the group assigned. The dose of iron isomaltoside will be determined based on patient's body weight using the manufacturer's recommendation. Serum hemoglobin, hematocrit, iron, ferritin, transferrin saturation, and phosphorus level will be checked at preoperative day, postoperative day 1, 7, and 30.
The primary outcome is the incidence of postoperative anemia at 30 days after surgery. Secondary outcomes included the incidence and amount of red blood cell transfusion during admission period, hospital length of stay, the incidence of surgical site infection, and quality of life during postoperative period.
- Conditions
- Anemia, Knee Arthropathy
- Being tested
- Iron Isomaltoside 1000
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Isomaltoside 1000Drug
Also called treatment
Iron Isomaltoside 1000 would be intravenously administrated to treatment group after main procedure of total knee arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients in this group would receive Iron Isomaltoside 1000 (Monofer®) after main procedure of total knee arthroplasty. The dose of iron isomaltoside would be determined based on the patient's body weight. Receives: Drug: Iron Isomaltoside 1000 |
| Control | No intervention | Patients in this group would receive 100ml of normal saline after main procedure of total knee arthroplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative anemia
Incidence of postoperative anemia at 30 days after surgery
Measured: 30 days after surgery
Secondary outcomes (11)
Transfusion
Incidence and amount of red blood cell transfusion during admission
Measured: During admission period for surgery, an average of 2 weeks
Hemoglobin
serum hemoglobin level (g/dL)
Measured: 1 day, 7 days, and 30 days after surgery
Hematocrit
Hematocrit level (%)
Measured: 1 day, 7 days, and 30 days after surgery
Iron
serum iron level (μg/dL)
Measured: 1 day, 7 days, and 30 days after surgery
Ferritin
serum ferritin level (ng/mL)
Measured: 1 day, 7 days, and 30 days after surgery
Transferrin saturation
Transferrin saturation (%)
Measured: 1 day, 7 days, and 30 days after surgery
Phosphorus
Serum phosphorus level (mg/dL)
Measured: 1 day, 7 days, and 30 days after surgery
Surgical site infection
Incidence of surgical site infection
Measured: During admission period for surgery, an average of 2 weeks
Hospital length of stay
Hospital length of stay (days)
Measured: During admission period for surgery, an average of 2 weeks
Quality of life using EQ-5D
Assessment of quality of life during postoperative periods using EQ-5D (EuroQol-5 Dimension) questionaire
Measured: 30 days after surgery
Quality of life using FACT-An
Assessment of quality of life during postoperative periods using FACT-An (The Functional Assessment of Cancer Therapy-Anemia) questionaire
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start29 Mar 2018
- Primary completion16 Apr 2019
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, Pf., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470649
- Sponsor's protocol ID
- H-1709-079-885
- Status last verified
- Apr 2019
- First submitted
- 13 Mar 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoo S, Bae J, Ro DH, Han HS, Lee MC, Park SK, Lim YJ, Bahk JH, Kim JT. Efficacy of intra-operative administration of iron isomaltoside for preventing postoperative anaemia after total knee arthroplasty: A randomised controlled trial. Eur J Anaesthesiol. 2021 Apr 1;38(4):358-365. doi: 10.1097/EJA.0000000000001389.
PubMed 33259451
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Iron Isomaltoside on Postoperative Anemia in Patients Underwent Total Knee Arthroplasty: A Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03470649
- Acronym / sponsor ID
- H-1709-079-885
- Conditions
- Anemia, Knee Arthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 20 Mar 2018 (actual)
- 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.
Postoperative anemia is a frequent complication after total knee arthroplasty, with an incidence of 87%. Iron supplementation is known to be effective in treatment and prevention of postoperative anemia. The investigators examined the effect of intravenous iron isomaltoside (Monofer®) administration on postoperative anemia and transfusion requirements in patients undergoing total knee arthroplasty.
Participants undergoing total knee arthroplasty will be randomly assigned to treatment group or control group. After main procedure of total knee arthroplasty, iron isomaltoside 1000 (Monofer®) or normal saline will be intravenously administered depending on the group assigned. The dose of iron isomaltoside will be determined based on patient's body weight using the manufacturer's recommendation. Serum hemoglobin, hematocrit, iron, ferritin, transferrin saturation, and phosphorus level will be checked at preoperative day, postoperative day 1, 7, and 30.
The primary outcome is the incidence of postoperative anemia at 30 days after surgery. Secondary outcomes included the incidence and amount of red blood cell transfusion during admission period, hospital length of stay, the incidence of surgical site infection, and quality of life during postoperative period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Iron Isomaltoside 1000Patients in this group would receive Iron Isomaltoside 1000 (Monofer®) after main procedure of total knee arthroplasty. The dose of iron isomaltoside would be determined based on the patient's body weight. |
| Control | No intervention | –Patients in this group would receive 100ml of normal saline after main procedure of total knee arthroplasty. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing total knee arthroplasty
Key exclusion criteria (10 listed)
- bilateral total knee arthroplasty
- hematochromatosis or hemosiderosis
- hemolytic anemia
- history of drug allergy
- liver cirrhosis or hepatitis
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 Isomaltoside 1000Also: treatmentIron Isomaltoside 1000 would be intravenously administrated to treatment group after main procedure of total knee arthroplasty. | Drug | Treatment |
Primary outcome
Postoperative anemia
Time frame: 30 days after surgery
Incidence of postoperative anemia at 30 days after surgery
11 secondary outcomes
Transfusion
Time frame: During admission period for surgery, an average of 2 weeks
Hemoglobin
Time frame: 1 day, 7 days, and 30 days after surgery
Hematocrit
Time frame: 1 day, 7 days, and 30 days after surgery
Iron
Time frame: 1 day, 7 days, and 30 days after surgery
Ferritin
Time frame: 1 day, 7 days, and 30 days after surgery
Transferrin saturation
Time frame: 1 day, 7 days, and 30 days after surgery
Phosphorus
Time frame: 1 day, 7 days, and 30 days after surgery
Surgical site infection
Time frame: During admission period for surgery, an average of 2 weeks
Hospital length of stay
Time frame: During admission period for surgery, an average of 2 weeks
Quality of life using EQ-5D
Time frame: 30 days after surgery
Quality of life using FACT-An
Time frame: 30 days after surgery
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 18 Apr 2019.
- Derived from this study: PubMed 33259451Yoo S, Bae J, Ro DH, Han HS, Lee MC, Park SK, Lim YJ, Bahk JH, Kim JT. Efficacy of intra-operative administration of iron isomaltoside for preventing postoperative anaemia after total knee arthroplasty: A randomised controlled trial. Eur J Anaesthesiol. 2021 Apr 1;38(4):358-365. doi: 10.1097/EJA.0000000000001389.
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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.
Jin-Tae Kim, Pf. principal investigator
Seoul National University 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 Isomaltoside 1000 in people with Anemia and Knee Arthropathy, run by Seoul National University 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 1 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 18 Apr 2019. 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. 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 anemia (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470649, which also lists 1 linked publication.
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 18 Apr 2019.