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IV Iron in Association With Tranexamic Acid for Hip Fracture

Primary Purpose

Hip Fracture, Anemia

Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
tranexamic acid (Exacyl®)
intravenous iron (Ferroven®)
Saline
Sponsored by
Institut Kassab d'Orthopédie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Fracture focused on measuring hip fracture, anemia, blood transfusion, tranexamic acid, intravenous iron

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Mohamed Kassab d'Orthopédie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Tranexamic acid - intravenous iron

Tranexamic acid

Placebo

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

transfusion
percentage of patients who receive red-cell transfusion during hospitalization

Secondary Outcome Measures

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

Full Information

First Posted
April 14, 2015
Last Updated
April 28, 2015
Sponsor
Institut Kassab d'Orthopédie
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1. Study Identification

Unique Protocol Identification Number
NCT02428868
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Kassab d'Orthopédie

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture, Anemia
Keywords
hip fracture, anemia, blood transfusion, tranexamic acid, intravenous iron

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid - intravenous iron
Arm Type
Experimental
Arm Description
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.
Arm Title
Tranexamic acid
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
20 mL saline, in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.
Intervention Type
Drug
Intervention Name(s)
tranexamic acid (Exacyl®)
Intervention Description
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
Intervention Name(s)
intravenous iron (Ferroven®)
Intervention Description
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
Other
Intervention Name(s)
Saline
Intervention Description
20 mL saline in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.
Primary Outcome Measure Information:
Title
transfusion
Description
percentage of patients who receive red-cell transfusion during hospitalization
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Average red-cell packs per patient
Time Frame
5 days
Title
blood loss
Description
Calculated blood loss per patient from admission to day 5 postoperatively
Time Frame
5 days
Title
haemoglobin level
Description
haemoglobin level at day 1 postoperatively
Time Frame
day 1
Title
haemoglobin level
Time Frame
day 2
Title
haemoglobin level
Time Frame
day 5
Title
haemoglobin level
Time Frame
day 30
Title
haemoglobin level
Time Frame
day 60
Title
Thromboembolic events
Description
stroke or transient ischemic attack, venous thromboembolism and clinically recognized myocardial during hospital stay and until 60 days postoperatively.
Time Frame
day 60
Title
Post-operative bacterial infection
Description
urinary tract infection, lower respiratory tract infection, pneumonia and superficial or deep wound infection.
Time Frame
day 60
Title
number of days in hospital
Description
expected period of approximately 5 days
Time Frame
day 10
Title
Functional mobility
Description
ability to walk more than 10 m or outside home 60 days after hospital discharge.
Time Frame
day 60
Title
mortality
Description
in-hospital mortality
Time Frame
5 days
Title
mortality
Time Frame
day 30
Title
mortality
Time Frame
day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olfa Kaabachi, Professor
Phone
+21698317381
Email
olfa.kaabachi@gnet.tn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olfa Kaabachi, Professor
Organizational Affiliation
Institut Mohamed Kassab d'Orthopédie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Mohamed Kassab d'Orthopédie
City
La Manouba
Country
Tunisia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim Raies, A. Professor
Phone
0021655208602
Email
karim.raies@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
19707842
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.
Results Reference
background
PubMed Identifier
22168590
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.
Results Reference
background
PubMed Identifier
20613475
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.
Results Reference
result
PubMed Identifier
20630042
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.
Results Reference
result
PubMed Identifier
19926634
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.
Results Reference
result

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IV Iron in Association With Tranexamic Acid for Hip Fracture

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