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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric carboxymaltose | Drug | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| Hb increase from baseline till day of surgery | Hb increase from baseline till day of surgery | Postoperative 8 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients requiring alternative anaemia management therapy | Percentage of patients requiring alternative anaemia management therapy | Percentage of patients requiring alternative anaemia management therapy up to 8weeks |
| Self-reported patient assessment of EQ-5D (EuroQol-5 dimension ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong In, MD, PhD | Contact | 8290445228 | iy1000@catholic.ac.kr | |
| Man Soo Kim, MD | Contact | 8272333875 | kms3779@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Yong In, MD, PhD | The Catholic Univerisity of Korea Seoul St Mary's hospital | Study Chair |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
|
| 0.9% Normal Saline | Drug | 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. |
|
Self-reported patient assessment of EQ-5D (EuroQol-5 dimension ) |
| baseline and postoperative 4, 8 weeks |
| WOMAC(Western Ontario and McMaster University Arthritis Index ) scale | WOMAC(Western Ontario and McMaster University Arthritis Index ) scale | baseline and postoperative 2, 4, 8 weeks |
| Brief pain inventory | Brief pain inventory | baseline and postoperative 2, 4, 8 weeks |
| D012216 |
| Rheumatic Diseases |