Hip FractureNCT02428868
IV Iron in Association With Tranexamic Acid for Hip Fracture
A study testing tranexamic acid (Exacyl®), intravenous iron (Ferroven®) and Saline in people with Hip Fracture and Anemia, run by Institut Kassab d'Orthopédie at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fracture, Anemia
- What is being tested?
- tranexamic acid (Exacyl®), intravenous iron (Ferroven®) and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTunisia
- Study dates
- Apr 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing hip fracture surgery within 72 h after trauma.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Institut Mohamed Kassab d'Orthopédie
Manouba, La Manouba
Karim Raies, A. Professor, 0021655208602, karim.raies@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Hip Fracture, Anemia
- Being tested
- tranexamic acid (Exacyl®), intravenous iron (Ferroven®), Saline
- Keywords
- hip fracture, anemia, blood transfusion, tranexamic acid, intravenous iron
- Medical subject headings
- Hip Fractures, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranexamic acid (Exacyl®)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®)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.
SalineOther
20 mL saline in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid - intravenous iron | Experimental | 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. Receives: Drug: tranexamic acid (Exacyl®); Drug: intravenous iron (Ferroven®) |
| Tranexamic acid | Active comparator | 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. Receives: Drug: tranexamic acid (Exacyl®) |
| Placebo | Placebo comparator | 20 mL saline, in 30 minutes, five minutes before skin incision and 20 ml 3 hours later. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
transfusion
percentage of patients who receive red-cell transfusion during hospitalization
Measured: 5 days
Secondary outcomes (14)
Average red-cell packs per patient
Measured: 5 days
blood loss
Calculated blood loss per patient from admission to day 5 postoperatively
Measured: 5 days
haemoglobin level
haemoglobin level at day 1 postoperatively
Measured: day 1
haemoglobin level
Measured: day 2
haemoglobin level
Measured: day 5
haemoglobin level
Measured: day 30
haemoglobin level
Measured: day 60
Thromboembolic events
stroke or transient ischemic attack, venous thromboembolism and clinically recognized myocardial during hospital stay and until 60 days postoperatively.
Measured: day 60
Post-operative bacterial infection
urinary tract infection, lower respiratory tract infection, pneumonia and superficial or deep wound infection.
Measured: day 60
number of days in hospital
expected period of approximately 5 days
Measured: day 10
Functional mobility
ability to walk more than 10 m or outside home 60 days after hospital discharge.
Measured: day 60
mortality
in-hospital mortality
Measured: 5 days
mortality
Measured: day 30
mortality
Measured: day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Kassab d'Orthopédie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olfa Kaabachi, Professor, Principal investigator, Institut Mohamed Kassab d'Orthopédie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428868
- Sponsor's protocol ID
- P-2015004/AR
- Status last verified
- Apr 2015
- First submitted
- 14 Apr 2015
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19707842Carson 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.
PubMed 22168590Spahn 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.
PubMed 20613475Serrano-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.
PubMed 20630042Zufferey 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.
PubMed 19926634
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Combined Tranexamic Acid and Intravenous Iron for Hip Fracture Surgery in Elderly
- ClinicalTrials.gov ID
- NCT02428868
- Acronym / sponsor ID
- P-2015004/AR
- Conditions
- Hip Fracture, Anemia
- Keywords
- hip fracture, anemia, blood transfusion, tranexamic acid, intravenous iron
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institut Kassab d'OrthopédieUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid - intravenous iron | Experimental | Drug: tranexamic acid (Exacyl®), Drug: intravenous iron (Ferroven®)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. |
| Tranexamic acid | Active comparator | Drug: tranexamic acid (Exacyl®)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. |
| Placebo | Placebo comparator | Other: Saline20 mL saline, in 30 minutes, five minutes before skin incision and 20 ml 3 hours later. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing hip fracture surgery within 72 h after trauma.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Tranexamic acid, Tranexamic acid - intravenous iron |
| 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. | Drug | Tranexamic acid - intravenous iron |
| Saline20 mL saline in 30 minutes, five minutes before skin incision and 20 ml 3 hours later. | Other | Placebo |
Primary outcome
transfusion
Time frame: 5 days
percentage of patients who receive red-cell transfusion during hospitalization
14 secondary outcomes
Average red-cell packs per patient
Time frame: 5 days
blood loss
Time frame: 5 days
haemoglobin level
Time frame: day 1
haemoglobin level
Time frame: day 2
haemoglobin level
Time frame: day 5
haemoglobin level
Time frame: day 30
haemoglobin level
Time frame: day 60
Thromboembolic events
Time frame: day 60
Post-operative bacterial infection
Time frame: day 60
number of days in hospital
Time frame: day 10
Functional mobility
Time frame: day 60
mortality
Time frame: 5 days
mortality
Time frame: day 30
mortality
Time frame: day 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Background: PubMed 19707842Hagino 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.
- Background: PubMed 22168590Carson 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 publication: PubMed 20613475Spahn 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 publication: PubMed 20630042Serrano-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 publication: PubMed 19926634Zufferey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olfa Kaabachi, Professor principal investigator
Institut Mohamed Kassab d'Orthopédie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tranexamic acid (Exacyl®), intravenous iron (Ferroven®) and Saline in people with Hip Fracture and Anemia, run by Institut Kassab d'Orthopédie at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olfa Kaabachi, Professor (+21698317381, olfa.kaabachi@gnet.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transfusion (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02428868, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.