Preventing postoperative anaemia in knee arthroplasty and impact of intravenous iron supplementation on postoperative recovery

Preventing postoperative anaemia in total knee arthroplasty and impact of intravenous iron supplementation on postoperative functional recovery : a randomized clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001252-41-BE

Enrollment

Registered

2022-06-20

Start date

2022-07-08

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty

Interventions

Trade Name: Injectafer Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Ferric carboxymaltose CAS Number: 9007-72-1 Concentration unit: mg/ml milligram(s)/millilitre Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: >18 yo patients scheduled for total knee arthroplasty with preoperative serum hemoglobin assay between 11 and 13 g/dL Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26

Exclusion criteria

Exclusion criteria: Exclusion: - Refusal - Contraindications to IV iron - Hb>13g/dLou 30 MDRD - Liver failure - Pregnancy - Blood transfusion during last 30 days - BMI >35

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): Quality-of-Recovery with 15 items at 15 days after surgery;Timepoint(s) of evaluation of this end point: 15 days after surgery	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): Quality-of-Recovery with 15 items at 15 days after surgery;Timepoint(s) of evaluation of this end point: 15 days after surgery

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Secondary

Measure	Time frame
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;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	—

Measure

Time frame

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;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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Countries

Belgium

Contacts

Public ContactNicolas Piette

CHU de Liège

+3242843824

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026