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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
150
1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later
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.
20 mL saline in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.
Institut Mohamed Kassab d'Orthopédie
Manouba, La Manouba, Tunisia
transfusion
percentage of patients who receive red-cell transfusion during hospitalization
Time frame: 5 days
Average red-cell packs per patient
Time frame: 5 days
blood loss
Calculated blood loss per patient from admission to day 5 postoperatively
Time frame: 5 days
haemoglobin level
haemoglobin level at day 1 postoperatively
Time frame: day 1
haemoglobin level
Time frame: day 2
haemoglobin level
Time frame: day 5
haemoglobin level
Time frame: day 30
haemoglobin level
Time frame: day 60
Thromboembolic events
stroke or transient ischemic attack, venous thromboembolism and clinically recognized myocardial during hospital stay and until 60 days postoperatively.
Time frame: day 60
Post-operative bacterial infection
urinary tract infection, lower respiratory tract infection, pneumonia and superficial or deep wound infection.
Time frame: day 60
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
number of days in hospital
expected period of approximately 5 days
Time frame: day 10
Functional mobility
ability to walk more than 10 m or outside home 60 days after hospital discharge.
Time frame: day 60
mortality
in-hospital mortality
Time frame: 5 days
mortality
Time frame: day 30
mortality
Time frame: day 60