IV Iron in Association With Tranexamic Acid for Hip Fracture
- Conditions
- Hip FractureAnemia
- Interventions
- Drug: tranexamic acid (Exacyl®)Other: SalineDrug: intravenous iron (Ferroven®)
- Registration Number
- NCT02428868
- Lead Sponsor
- Institut Kassab d'Orthopédie
- Brief Summary
It is a prospective randomized controlled study aiming to test if tranexamic acid combined to intravenous iron before and after surgery for hip fracture in elderly can decrease peri-operative red cell transfusion.
- Detailed Description
Hip fracture is an increasing problem. Anemia is a common finding in these patients with a prevalence ranging from 24% to 44% and is a strong negative prognostic marker. Several studies have explored whether interventions to improve anemia result in better outcomes. Thus, alternatives to allogenic red cell transfusion have been suggested in hip fracture, such as IV iron and tranexamic acid.
The aim of the study is to test the effect of combination of IV iron with tranexamic acid before and after surgery for hip fracture on incidence of peri-operative red cell transfusion.
It is a prospective randomized single-blinded monocentric study including 150 patients undergoing hip fracture surgery within 72 h after trauma aged ≥ 60 years divided in 3 groups: Group A (IV fer+Tranexamic acid), Group B (Tranexamic acid), Group C (placebo). The main outcome was percentage of patients who receive red-cell transfusion during hospitalization. Hemoglobin levels up to 60 days post-operatively and incidence of thrombotic events were secondary outcomes.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- Patients undergoing hip fracture surgery within 72 h after trauma.
- Vascular events within the last 2 months such as cerebrovascular accident (CVA), Myocardial infarction (MI), Venous Thromboembolism (VTE) and/or recurrent VTE or arterial thrombosis.
- Patients receiving anticoagulation therapy with warfarin or clopidogrel.
- History of seizures.
- Multiple fractures.
- Transfusion received during admission, prior to surgery (Hb< 8g/dl).
- Creatinine clearance less than 30 mL/min
- Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
- Coronary stent placement within the previous 6 months
- Disseminated intravascular coagulation
- Subarachnoid hemorrhage
- Allergy for tranexamic acid
- Hypersensitivity to Iron sucrose or any component of the formulation
- Clinical signs of acute thromboembolic event
- Malignancy
- Body weight > 100kg
- Advanced Dementia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tranexamic acid tranexamic acid (Exacyl®) IV Tranexamic acid (Exacyl®): 1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later. Tranexamic acid - intravenous iron intravenous iron (Ferroven®) IV iron (Ferroven®) : 2 vials of 10 mL containing each one 100 mg iron, diluted in 100 mL normal saline over 30 minutes before induction of anesthesia and repeated on day two and three. IV Tranexamic acid (Exacyl®): 1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later. Tranexamic acid - intravenous iron tranexamic acid (Exacyl®) IV iron (Ferroven®) : 2 vials of 10 mL containing each one 100 mg iron, diluted in 100 mL normal saline over 30 minutes before induction of anesthesia and repeated on day two and three. IV Tranexamic acid (Exacyl®): 1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later. Placebo Saline 20 mL saline, in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.
- Primary Outcome Measures
Name Time Method transfusion 5 days percentage of patients who receive red-cell transfusion during hospitalization
- Secondary Outcome Measures
Name Time Method Average red-cell packs per patient 5 days blood loss 5 days Calculated blood loss per patient from admission to day 5 postoperatively
haemoglobin level day 60 Thromboembolic events day 60 stroke or transient ischemic attack, venous thromboembolism and clinically recognized myocardial during hospital stay and until 60 days postoperatively.
Post-operative bacterial infection day 60 urinary tract infection, lower respiratory tract infection, pneumonia and superficial or deep wound infection.
number of days in hospital day 10 expected period of approximately 5 days
Functional mobility day 60 ability to walk more than 10 m or outside home 60 days after hospital discharge.
mortality day 60
Trial Locations
- Locations (1)
Institut Mohamed Kassab d'Orthopédie
🇹🇳La Manouba, Tunisia