Anemia, Hip Fracture
Conditions
Keywords
hip fracture, anemia, blood transfusion, tranexamic acid, intravenous iron
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.
Interventions
DRUGtranexamic 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
DRUGintravenous 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.
OTHERSaline
20 mL saline in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.
Sponsors
Institut Kassab d'Orthopédie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing hip fracture surgery within 72 h after trauma.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| transfusion | 5 days | percentage of patients who receive red-cell transfusion during hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood loss | 5 days | Calculated blood loss per patient from admission to day 5 postoperatively |
| haemoglobin level | day 1 | haemoglobin level at day 1 postoperatively |
| Thromboembolic events | day 60 | stroke or transient ischemic attack, venous thromboembolism and clinically recognized myocardial during hospital stay and until 60 days postoperatively. |
| Average red-cell packs per patient | 5 days | — |
| 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 | 5 days | in-hospital mortality |
| Post-operative bacterial infection | day 60 | urinary tract infection, lower respiratory tract infection, pneumonia and superficial or deep wound infection. |
Countries
Tunisia
Contacts
Primary ContactOlfa Kaabachi, Professor
Outcome results
None listed