Clinical trial NCT02428868: IV Iron in Association With Tranexamic Acid for Hip Fracture
Official title: Use of Combined Tranexamic Acid and Intravenous Iron for Hip Fracture Surgery in Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fracture
Anemia
Keywords: hip fracture
anemia
blood transfusion
tranexamic acid
intravenous iron
Lead sponsor: Institut Kassab d'Orthopédie
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: transfusion
timeFrame: 5 days
Secondary outcomes:
measure: Average red-cell packs per patient
timeFrame: 5 days
measure: blood loss
timeFrame: 5 days
measure: haemoglobin level
timeFrame: day 1
measure: haemoglobin level
timeFrame: day 2
measure: haemoglobin level
timeFrame: day 5
measure: haemoglobin level
timeFrame: day 30
measure: haemoglobin level
timeFrame: day 60
measure: Thromboembolic events
timeFrame: day 60
measure: Post-operative bacterial infection
timeFrame: day 60
measure: number of days in hospital
timeFrame: day 10
measure: Functional mobility
timeFrame: day 60
measure: mortality
timeFrame: 5 days
measure: mortality
timeFrame: day 30
measure: mortality
timeFrame: day 60
Other outcomes:
Locations:
city: La Manouba
country: Tunisia
facility: Institut Mohamed Kassab d'Orthopédie
Study officials:
affiliation: Institut Mohamed Kassab d'Orthopédie
name: Olfa Kaabachi, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hagino T, Ochiai S, Sato E, Maekawa S, Wako M, Haro H. The relationship between anemia at admission and outcome in patients older than 60 years with hip fracture. J Orthop Traumatol. 2009 Sep;10(3):119-22. doi: 10.1007/s10195-009-0060-8. Epub 2009 Aug 26.
citation: Carson JL, Terrin ML, Noveck H, Sanders DW, Chaitman BR, Rhoads GG, Nemo G, Dragert K, Beaupre L, Hildebrand K, Macaulay W, Lewis C, Cook DR, Dobbin G, Zakriya KJ, Apple FS, Horney RA, Magaziner J; FOCUS Investigators. Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med. 2011 Dec 29;365(26):2453-62. doi: 10.1056/NEJMoa1012452. Epub 2011 Dec 14.
citation: Spahn DR. Anemia and patient blood management in hip and knee surgery: a systematic review of the literature. Anesthesiology. 2010 Aug;113(2):482-95. doi: 10.1097/ALN.0b013e3181e08e97.
citation: Serrano-Trenas JA, Ugalde PF, Cabello LM, Chofles LC, Lazaro PS, Benitez PC. Role of perioperative intravenous iron therapy in elderly hip fracture patients: a single-center randomized controlled trial. Transfusion. 2011 Jan;51(1):97-104. doi: 10.1111/j.1537-2995.2010.02769.x.
citation: Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: 10.1093/bja/aep314.