IV Iron in Association With Tranexamic Acid for Hip Fracture

April 28, 2015 updated by: Institut Kassab d'Orthopédie

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

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.

Study Overview

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

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • La Manouba, Tunisia
        • Institut Mohamed Kassab d'Orthopédie
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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
5 days

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
Calculated blood loss per patient from admission to day 5 postoperatively
5 days
haemoglobin level
Time Frame: day 1
haemoglobin level at day 1 postoperatively
day 1
haemoglobin level
Time Frame: day 2
day 2
haemoglobin level
Time Frame: day 5
day 5
haemoglobin level
Time Frame: day 30
day 30
haemoglobin level
Time Frame: day 60
day 60
Thromboembolic events
Time Frame: day 60
stroke or transient ischemic attack, venous thromboembolism and clinically recognized myocardial during hospital stay and until 60 days postoperatively.
day 60
Post-operative bacterial infection
Time Frame: day 60
urinary tract infection, lower respiratory tract infection, pneumonia and superficial or deep wound infection.
day 60
number of days in hospital
Time Frame: day 10
expected period of approximately 5 days
day 10
Functional mobility
Time Frame: day 60
ability to walk more than 10 m or outside home 60 days after hospital discharge.
day 60
mortality
Time Frame: 5 days
in-hospital mortality
5 days
mortality
Time Frame: day 30
day 30
mortality
Time Frame: day 60
day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Olfa Kaabachi, Professor, Institut Mohamed Kassab d'Orthopédie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

April 1, 2015

More Information

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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