NCT02428868

IV Iron in Association With Tranexamic Acid for Hip Fracture

Use of Combined Tranexamic Acid and Intravenous Iron for Hip Fracture Surgery in Elderly

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Institut Kassab d'Orthopédie · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Fracture
• Anemia

Interventions

Type	Name	Description
DRUG	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
DRUG	intravenous 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.
OTHER	Saline	20 mL saline in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-04-29
• Last updated: 2015-04-29

Locations

1 site across 1 country: Tunisia