FERRIC DERISOMALTOSE for Hip fracture

Inclusion criteria

• {"criterion_text":"-\t65 years of age or older\n-\tAcute proximal femur fracture surgery\n-\tA haemoglobin measurement ≤6,5 mmol/L (10.5 g/dL) on day 1 to 5 postoperatively\n-\tIndependent prefracture indoor walking ability, indoor NMS ≥ 2\n-\tAbility to speak and understand Danish\n- Able to provide informed consent on their own behalf"}

Exclusion criteria

• {"criterion_text":"-\tNo known allergy to intravenous iron\n-\tResiding permanently at a nursing home\n-\tHaematological conditions with a risk of iron overload e.g. haemochromatosis, hemosiderosis, or where alternative treatments are necessary e.g. haematological malignancies\n-\tOther contraindication to iron treatment, e.g. severe liver cirrhosis and hepatitis\n-\tSevere uncontrolled infection as assessed by the responsible clinician (e.g. bacteraemia or sepsis)\n-\tPlasma sodium levels below 125 or above 150 mmol/L on the day of inclusion\n-\tRenal replacement therapy\n-\tSevere dementia assessed by physician\n-\tRecent intravenous iron injection, 4 weeks prior to surgery\n-\tPatient declared terminal ill\n-\tPathologic Fracture"}

Primary endpoints

• {"endpoint_text":"- Participants will report their pre-fracture NMS at baseline. NMS will be assessed by phone at week 4 post-intervention and in-person at weeks 6 and 12. Mobility recovery from pre-fracture will be analyzed using repeated measures mixed linear models, with the primary endpoint being NMS after 6 weeks, estimated by least squares means difference","definition_or_measurement_approach":"NMS assessed by phone at week 4 and in-person at weeks 6 and 12; mobility recovery analysed using repeated measures mixed linear models; primary endpoint is New Mobility Score (NMS) at 6 weeks estimated by least squares means difference."}

Secondary endpoints

• {"endpoint_text":"- 1.\tHaemoglobin Blood test will be obtained, and haemoglobin analysed at baseline and following the 6- and 12-week patient visit.","definition_or_measurement_approach":"Haemoglobin measured on blood tests at baseline and at 6 and 12 weeks post-intervention."}
• {"endpoint_text":"- 2.\tRed blood cell transfusion requirement: This will be measured by the proportion of patients who receive at least one red blood cell unit and the amounts of units per patient on postoperative day (POD) 7 and POD 30 attained from electronic patient records.","definition_or_measurement_approach":"Proportion of patients receiving ≥1 red blood cell unit and units per patient at POD7 and POD30 from electronic patient records."}
• {"endpoint_text":"- 3.\tFatigue will be measured with ‘Verbal rating scale – Fatigue’ from 0, 4 and at 6 and 12 weeks after intervention","definition_or_measurement_approach":"Fatigue measured using Verbal Rating Scale – Fatigue at baseline, 4, 6 and 12 weeks."}
• {"endpoint_text":"- 4.\tQuality of life: This will be measured by dedicated staff using the questionnaire EQ-5D-5L and EQ VAS 0-100, on inclusion as a retrograde baseline the weeks prior to admission and at 6 and 12 weeks after intervention.","definition_or_measurement_approach":"Quality of life measured with EQ-5D-5L and EQ VAS (0-100) at baseline (retrograde pre-admission) and at 6 and 12 weeks."}
• {"endpoint_text":"- 5.\tFear of falls: Short Falls efficacy scale International (Short-FES-I) for assessment of concern for falling during different activities measured at baseline and at 6 and 12 weeks after intervention","definition_or_measurement_approach":"Fear of falls assessed with Short-FES-I at baseline and at 6 and 12 weeks."}
• {"endpoint_text":"- 6. 30 second Sit-to-Stand-Test (STS) The test uses a chair placed against a wall, with the participant seated in the middle and arms crossed at the chest. Participants are encouraged to stand and fully sit as many times as possible within 30 seconds, with correct form monitored by the tester. Measured at baseline, 6 and 12 weeks. Measured at baseline, 6 and 12 weeks. Measured at baseline, 6 and 12 weeks. Measured at baseline and at 6 and 12 weeks.","definition_or_measurement_approach":"30-second Sit-to-Stand Test measured at baseline, 6 and 12 weeks; number of correct stands in 30 seconds recorded."}
• {"endpoint_text":"- 6.\tActivity of daily living: Barthel Index 20 Barthel measured at baseline and at 6 and 12 weeks after intervention.","definition_or_measurement_approach":"Activities of daily living measured by Barthel Index at baseline and at 6 and 12 weeks."}
• {"endpoint_text":"- 7.\tPain: Hip fracture-related pain during activity will be evaluated with the verbal rating scale, 0-4 points, at baseline and at 6 and 12 weeks after intervention.","definition_or_measurement_approach":"Pain during activity evaluated with verbal rating scale (0-4) at baseline and at 6 and 12 weeks."}
• {"endpoint_text":"- 8.\tDays alive and at home up to 30 days, assessed at 6 week follow up","definition_or_measurement_approach":"Days alive and at home up to 30 days assessed at 6-week follow-up."}
• {"endpoint_text":"- 9.\tSerious adverse event: SAE defined following the ICH – GCP guidelines. Will be assessed at the 6 weeks follow up.","definition_or_measurement_approach":"SAE defined per ICH-GCP and assessed at 6 weeks."}
• {"endpoint_text":"- 10.\tMortality: 90 days following enrolment it is obtained if patients are alive from patient electronic medical records and from this survival, 30 and 90 mortality is calculated","definition_or_measurement_approach":"Mortality assessed up to 90 days from enrolment using electronic medical records; 30- and 90-day mortality calculated."}

Denmark

Earliest CTIS Part Ii Submission Date

29-01-2025

Latest Decision Or Authorization Date

09-02-2025

Processing Time Days

11

Number Of Sites

3

Number Of Participants

210

Primary sponsor

Full Name

Region Hovedstaden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}