E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Preventing anemia in Total Knee Arthroplasty |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Randomized controlled trial will aim to investigate the efficacy of treatment of preoperative anemia with iron isomaltoside administration from the perspective of functional recovery. This evaluation will be based on validated clinical questionnaires of recovery after surgery. |
|
E.2.2 | Secondary objectives of the trial |
5Q-5D-5L score at day 1, 3, 7, 15, and 30 FSS (Fatigue Severity Scale) score at day 7, 15, 30 and 90 The biological criteria studied will be : Measurement of hemoglobin, hematocrit, reticulocytes, serum iron, transferrin saturation coefficient and serum ferritin at day 1, 3 and 30. The rate of transfusion of labile blood products in both groups. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
>18 yo patients scheduled for total knee arthroplasty with preoperative serum hemoglobin assay between 11 and 13 g/dL |
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E.4 | Principal exclusion criteria |
Exclusion: - Refusal - Contraindications to IV iron - Hb>13g/dLou<11g/dL - Iron metabolism disorders - Renal failure GFR > 30 MDRD - Liver failure - Pregnancy - Blood transfusion during last 30 days - BMI >35 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Quality-of-Recovery with 15 items at 15 days after surgery |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary endpoints: Measurement of hemoglobin, hematocrit, reticulocytes, serum iron, transferrin saturation coefficient, and serum ferritin at D1 and D3. Transfusion rate of labile blood products in both groups Measurement of fatigue interference with the FSS (Fatigue Severity Scale) at 7, 15, 30, and 90 days after surgery. Measurement of the quality of postoperative recovery with the Quality- of-Recovery- 15 (QoR-15) score and the 5Q-5D-5L score at D1-3-7-15-30 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Measurement of hemoglobin, hematocrit, reticulocytes, serum iron, transferrin saturation coefficient, and serum ferritin at Day 1 and Day 3 after surgery. First 7 days after surgery: Transfusion rate of labile blood products in both groups Measurement of fatigue interference with the FSS (Fatigue Severity Scale) at 7, 15, 30, and 90 days after surgery. Measurement of the quality of postoperative recovery with the Quality- of-Recovery- 15 (QoR-15) score and the 5Q-5D-5L score at Day 1-3-7- 15-30 after surgery |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial is reached at the last visit of the last subject (LVLS) at day 30 after surgery |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |