A study of whether giving iron into the veins may be helpful for patients with broken hips.
Phase 1
- Conditions
- Anaemia following hip fractureTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-003233-34-GB
- Lead Sponsor
- niversity of Nottingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Primary hip fracture Aged over 70 Able to consent for themselves
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
Exclusion Criteria
Undisplaced intracapsular fractures (very low transfusion requirements) Contra-indications to intravenous iron Currently taking anti-platelet drugs other than aspirin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To see what effects intravenous iron has on other markers of red cell production and to see whether a full scale trial is feasible.;Primary end point(s): Reticulocyte count at day 7;Timepoint(s) of evaluation of this end point: Measured each day. Primay end point is at day 7;Main Objective: To determine whether intravenous iron given in the first few days following hip fracture is effective in stimulating red cell production.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Haematological• Haematopoietic indices: FBC, serum transferrin receptor concentrations. Collected daily for 7 days following admission. • Number of patients requiring blood transfusion during hospital admission • Transfusion index (units / patient) Patient outcome • Postoperative infectious complications • Cardiovascular complications • Length of acute hospital stay • Functional mobility at days 1 – 3: assessed using Cumulated Ambulation Score • Transfusion related costs: consumables, nursing time. • Overall acute healthcare costs: estimated from length of stay, investigations, drug costs.;Timepoint(s) of evaluation of this end point: During first 7 days for laboratory / mobility endpoints. Notes review for length of stay.