IV Iron in Association With Tranexamic Acid for Hip Fracture

Institut Kassab d'Orthopédie

Status: Unknown

Conditions: Anemia; Hip Fracture

Treatments: Other: Saline; Drug: intravenous iron (Ferroven®); Drug: tranexamic acid (Exacyl®)

Study type: Interventional

Funder types: Other

Identifiers

NCT02428868

P-2015004/AR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups, including a placebo group

Tranexamic acid - intravenous iron

Experimental group

Description:

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.

Treatment:

Drug: intravenous iron (Ferroven®)

Drug: tranexamic acid (Exacyl®)

Tranexamic acid

Active Comparator group

Description:

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.

Treatment:

Drug: tranexamic acid (Exacyl®)

Placebo

Placebo Comparator group

Description:

20 mL saline, in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.

Treatment:

Other: Saline