IV Iron in Association With Tranexamic Acid for Hip Fracture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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

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Hip Fracture Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

tranexamic acid (Exacyl®)

Intervention Type DRUG

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®)

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

tranexamic acid (Exacyl®)

Intervention Type DRUG

1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later

Placebo

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Saline

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No