Postoperative AnemiaPhase 4NCT03561480
Effect of Postoperative Ferric Carboxymaltose
A Phase 4 study testing Ferric carboxymaltose and 0.9% Normal Saline in people with Postoperative Anemia and Knee Osteoarthritis, run by The Catholic University of Korea.
Trial summary
The primary purpose of this study is to evaluate the safety and efficacy of postoperative intravenous ferric carboxymaltose in patients with anemia undergoing Simultaneous Bilateral Total knee replacement in terms of Quality of life (QOL) and objective measures (Hemoglobin and Iron parameters). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Postoperative Anemia, Knee Osteoarthritis, Total Knee Arthroplasty
- What is being tested?
- Ferric carboxymaltose and 0.9% Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 11 Jun 2018to 11 Dec 2019
- Phase
- Phase 4
- 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
- > 18 years of age and signed written informed consent
- Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery)
- Hb < 10.0 g/dl after operation
- Ferritin < 100 μg/l or 100-300 with transferrin saturation < 20%
Who cannot join
- Suspicion of iron overload (Ferritin >300 μg/l or/and transferrin saturation>50%)
- Active severe infection/inflammation (defined as serum C reactive protein > 20 mg/l) or diagnosed malignancy
- Folate-and/or Vitamin B12 deficiency (according to local lab reference range)
- Known history of hepatitis B/C or HIV-positive
- Liver values 3 times higher than normal
- Immunosuppressive or myelosuppressive therapy
Show all 14Show fewer
- A concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients.
- Pregnancy or lactation
- Transfusion within 1 month prior to study inclusion, erythropoietin treatment with in the last 4 weeks, any iron treatment within 4 weeks prior to the inclusion in the trail
- Participation in any other therapeutic trial within the previous month
- History of thromboembolic events in the family or the patient
- Severe peripheral, coronary or carotid artery disease
- Bodyweight < 50 kg
- Patients not able to understand the German language
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Postoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty : A Randomized, Controlled, Double-Blind Trial
The primary purpose of this study is to evaluate the safety and efficacy of postoperative intravenous ferric carboxymaltose in patients with anemia undergoing Simultaneous Bilateral Total knee replacement in terms of Quality of life (QOL) and objective measures (Hemoglobin and Iron parameters).
Read the detailed description
Both preoperative and postoperative anaemia are common in patients undergoing total knee arthroplasty. Allogeneic RBC (red blood cell) transfusion and anaemia are related with higher postoperative mortality and morbidity. It is important to have a strategy of patient blood management.
Hb(hemoglobin) level of 10 g/dl will be used as a cut-off value for our study. In postoperative period in total knee arthroplasty for osteoarthritis, consented patients with postoperative anemia will be administered Ferinject® or placebo (normal saline) based on the results of randomization.
Study Group: Ferinject® administration as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg(milligram) single administration) for body weight ≥50 Kg (kilogram) or 6 minutes (for 500mg(milligram) single administration) for body weight < 50Kg( kilogram) .
Control Group: Placebo in the form of normal saline administration as same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL(milliliter) as infusion or 20mL(milliliter) as bolus injection) for body weight ≥50 Kg ( kilogram) or 6 minutes (100mL normal as infusion or 10mL(milliliter) as bolus injection) for body weight <50 Kg (kilogram).
- Being tested
- Ferric carboxymaltose, 0.9% Normal Saline
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Also called Ferinject®
Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50Kg .
0.9% Normal SalineDrug
Placebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight <50 Kg.
| Study group | Role | What they receive |
|---|---|---|
| Ferric carboxymaltose group | Experimental | Ferinject®to be administered as IV drip infusion or undiluted bolus injection to consented patients with postoperative anemia after total knee arthroplasty. Receives: Drug: Ferric carboxymaltose |
| Placebo group | Active comparator | Placebo(0.9% Normal Saline) to be administered as IV drip infusion or bolus injection to consented patients with postoperative anemia after total knee arthroplasty. Receives: Drug: 0.9% Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hb increase from baseline till day of surgery
Hb increase from baseline till day of surgery
Measured: Postoperative 8 weeks from baseline
Secondary outcomes (4)
Percentage of patients requiring alternative anaemia management therapy
Percentage of patients requiring alternative anaemia management therapy
Measured: Percentage of patients requiring alternative anaemia management therapy up to 8weeks
Self-reported patient assessment of EQ-5D (EuroQol-5 dimension )
Self-reported patient assessment of EQ-5D (EuroQol-5 dimension )
Measured: baseline and postoperative 4, 8 weeks
WOMAC(Western Ontario and McMaster University Arthritis Index ) scale
WOMAC(Western Ontario and McMaster University Arthritis Index ) scale
Measured: baseline and postoperative 2, 4, 8 weeks
Brief pain inventory
Brief pain inventory
Measured: baseline and postoperative 2, 4, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start11 Jun 2018 (estimated)
- Primary completion11 Jun 2019 (estimated)
- Study completion11 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnemiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong In, The Catholic University of Korea
- Investigators
- Yong In, MD, PhD, Study chair, The Catholic Univerisity of Korea Seoul St Mary's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561480
- Sponsor's protocol ID
- Ferric Carboxymaltose 2
- Status last verified
- Jun 2018
- First submitted
- 4 Jun 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty : A Randomized, Controlled, Double-Blind Trial
- ClinicalTrials.gov ID
- NCT03561480
- Acronym / sponsor ID
- Ferric Carboxymaltose 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 11 Jun 2018 (estimated)
- Primary completion
- 11 Jun 2019 (estimated)
- Study completion
- 11 Dec 2019 (estimated)
- First posted
- 19 Jun 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.
The primary purpose of this study is to evaluate the safety and efficacy of postoperative intravenous ferric carboxymaltose in patients with anemia undergoing Simultaneous Bilateral Total knee replacement in terms of Quality of life (QOL) and objective measures (Hemoglobin and Iron parameters).
Detailed description
Both preoperative and postoperative anaemia are common in patients undergoing total knee arthroplasty. Allogeneic RBC (red blood cell) transfusion and anaemia are related with higher postoperative mortality and morbidity. It is important to have a strategy of patient blood management.
Hb(hemoglobin) level of 10 g/dl will be used as a cut-off value for our study. In postoperative period in total knee arthroplasty for osteoarthritis, consented patients with postoperative anemia will be administered Ferinject® or placebo (normal saline) based on the results of randomization.
Study Group: Ferinject® administration as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg(milligram) single administration) for body weight ≥50 Kg (kilogram) or 6 minutes (for 500mg(milligram) single administration) for body weight < 50Kg( kilogram) .
Control Group: Placebo in the form of normal saline administration as same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL(milliliter) as infusion or 20mL(milliliter) as bolus injection) for body weight ≥50 Kg ( kilogram) or 6 minutes (100mL normal as infusion or 10mL(milliliter) as bolus injection) for body weight <50 Kg (kilogram).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric carboxymaltose group | Experimental | Drug: Ferric carboxymaltoseFerinject®to be administered as IV drip infusion or undiluted bolus injection to consented patients with postoperative anemia after total knee arthroplasty. |
| Placebo group | Active comparator | Drug: 0.9% Normal SalinePlacebo(0.9% Normal Saline) to be administered as IV drip infusion or bolus injection to consented patients with postoperative anemia after 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 (4 listed)
- > 18 years of age and signed written informed consent
- Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery)
- Hb < 10.0 g/dl after operation
- Ferritin < 100 μg/l or 100-300 with transferrin saturation < 20%
Key exclusion criteria (14 listed)
- Suspicion of iron overload (Ferritin >300 μg/l or/and transferrin saturation>50%)
- Active severe infection/inflammation (defined as serum C reactive protein > 20 mg/l) or diagnosed malignancy
- Folate-and/or Vitamin B12 deficiency (according to local lab reference range)
- Known history of hepatitis B/C or HIV-positive
- Liver values 3 times higher than normal
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 |
|---|---|---|
| Ferric carboxymaltoseAlso: Ferinject®Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50Kg . | Drug | Ferric carboxymaltose group |
| 0.9% Normal SalinePlacebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight <50 Kg. | Drug | Placebo group |
Primary outcome
Hb increase from baseline till day of surgery
Time frame: Postoperative 8 weeks from baseline
Hb increase from baseline till day of surgery
4 secondary outcomes
Percentage of patients requiring alternative anaemia management therapy
Time frame: Percentage of patients requiring alternative anaemia management therapy up to 8weeks
Self-reported patient assessment of EQ-5D (EuroQol-5 dimension )
Time frame: baseline and postoperative 4, 8 weeks
WOMAC(Western Ontario and McMaster University Arthritis Index ) scale
Time frame: baseline and postoperative 2, 4, 8 weeks
Brief pain inventory
Time frame: baseline and postoperative 2, 4, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
Yong In, MD, PhD study chair
The Catholic Univerisity of Korea Seoul St Mary's hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric carboxymaltose and 0.9% Normal Saline in people with Postoperative Anemia and Knee Osteoarthritis, run by The Catholic University of 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 14 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: status not confirmed, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong In, MD, PhD (8290445228, iy1000@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hb increase from baseline till day of surgery (time frame: Postoperative 8 weeks from baseline). 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 Jun 2018.