IV Iron in Association With Tranexamic Acid for Hip Fracture

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02428868
• Other study ID #: P-2015004/AR
• Status: Not yet recruiting
• Phase: N/A
• First received: April 14, 2015
• Last updated: April 28, 2015
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2015
• Source: Institut Kassab d'Orthopédie
• Contact: Olfa Kaabachi, Professor
• Phone: +21698317381
• Email: olfa.kaabachi[@]gnet.tn
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

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
• 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.

Locations

Country	Name	City	State
Tunisia	Institut Mohamed Kassab d'Orthopédie	La Manouba

Sponsors (1)

Lead Sponsor	Collaborator
Institut Kassab d'Orthopédie

Country where clinical trial is conducted

Tunisia, 

References & Publications (5)

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. — View 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. — View Citation

Serrano-Trenas JA, Ugalde PF, Cabello LM, Chofles LC, Lázaro PS, Benítez 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.1 — View 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. Review. — View 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transfusion	percentage of patients who receive red-cell transfusion during hospitalization	5 days	No
Secondary	Average red-cell packs per patient		5 days	No
Secondary	blood loss	Calculated blood loss per patient from admission to day 5 postoperatively	5 days	Yes
Secondary	haemoglobin level	haemoglobin level at day 1 postoperatively	day 1	No
Secondary	haemoglobin level		day 2	No
Secondary	haemoglobin level		day 5	No
Secondary	haemoglobin level		day 30	No
Secondary	haemoglobin level		day 60	No
Secondary	Thromboembolic events	stroke or transient ischemic attack, venous thromboembolism and clinically recognized myocardial during hospital stay and until 60 days postoperatively.	day 60	Yes
Secondary	Post-operative bacterial infection	urinary tract infection, lower respiratory tract infection, pneumonia and superficial or deep wound infection.	day 60	Yes
Secondary	number of days in hospital	expected period of approximately 5 days	day 10	No
Secondary	Functional mobility	ability to walk more than 10 m or outside home 60 days after hospital discharge.	day 60	No
Secondary	mortality	in-hospital mortality	5 days	Yes
Secondary	mortality		day 30	Yes
Secondary	mortality		day 60	Yes