- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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La Manouba, Tunisia
- Institut Mohamed Kassab d'Orthopédie
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Contact:
- Karim Raies, A. Professor
- Phone Number: 0021655208602
- Email: karim.raies@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tranexamic acid - intravenous iron
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. |
1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later
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.
|
Active Comparator: Tranexamic acid
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.
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1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later
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Placebo Comparator: Placebo
20 mL saline, in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.
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20 mL saline in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
transfusion
Time Frame: 5 days
|
percentage of patients who receive red-cell transfusion during hospitalization
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5 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average red-cell packs per patient
Time Frame: 5 days
|
5 days
|
|
blood loss
Time Frame: 5 days
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Calculated blood loss per patient from admission to day 5 postoperatively
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5 days
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haemoglobin level
Time Frame: day 1
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haemoglobin level at day 1 postoperatively
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day 1
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haemoglobin level
Time Frame: day 2
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day 2
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haemoglobin level
Time Frame: day 5
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day 5
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haemoglobin level
Time Frame: day 30
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day 30
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haemoglobin level
Time Frame: day 60
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day 60
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Thromboembolic events
Time Frame: day 60
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stroke or transient ischemic attack, venous thromboembolism and clinically recognized myocardial during hospital stay and until 60 days postoperatively.
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day 60
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Post-operative bacterial infection
Time Frame: day 60
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urinary tract infection, lower respiratory tract infection, pneumonia and superficial or deep wound infection.
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day 60
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number of days in hospital
Time Frame: day 10
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expected period of approximately 5 days
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day 10
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Functional mobility
Time Frame: day 60
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ability to walk more than 10 m or outside home 60 days after hospital discharge.
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day 60
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mortality
Time Frame: 5 days
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in-hospital mortality
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5 days
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mortality
Time Frame: day 30
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day 30
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mortality
Time Frame: day 60
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day 60
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olfa Kaabachi, Professor, Institut Mohamed Kassab d'Orthopédie
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-2015004/AR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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