This is a Study to Verify if Tranexamic Acid Can Reduce the Anemia After a Femoral Shaft Fractures Surgery (ORL-ORT-023)

October 5, 2021 updated by: Christian Candrian

Efficacy of Tranexamic Acid in Femoral Shaft Fractures Osteosynthesis; A Double Blind Randomized Controlled Trial

The investigators are going to evaluate if adding Tranexamic Acid in femoral shaft fractures surgery can lead to any advantages to the participants, namely if it can reduce post-operative anaemia, blood loss, blood transfusion requirements, length and cost of hospitalisation.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Lower limb procedures represent the majority of orthopaedic surgeries, including joint arthroplasties, sport medicine treatments, and fractures osteo-synthesis, with a rate over 500 per 100,000 population every year, increasing. Albeit being successful procedures routinely performed in the clinical practice, they are frequently encumbered by complications. In particular, femur fractures are common and frequently result in considerable blood loss, ranging from 900 to 1,500 ml, which exposes patients to postoperative anaemia and reduced functional recovery. Allogenic blood transfusions are financial burden, and, even more, they are associated with an unneglectable risk of serious complications, including infection, immuno-suppression, cardiovascular dysfunction, resulting in potentially life-threatening effects on patients. Various strategies have been attempted to minimize blood loss and the need for blood transfusion, and to this aim the use of hemostatic agents, in particular of tranexamic acid (TXA), has recently widely increased in orthopaedic lower limb surgery.

TXA is a synthetic anti-fibrinolytic agent that competitively blocks the lysine binding sites on plasminogen, thereby slowing the conversion of plasminogen to plasmin, thus preventing fibrin clot degradation. A large amount of randomized controlled trials and meta-analysis converge in showing that TXA, applied either through systemic or local administration, is effective in reducing blood loss and subsequent transfusions in lower limb fractures surgery, especially in hip fracture patients, as well in replacement procedures. However, there are still concerns about the risk of increasing venous thromboembolic (VTE) complications, such as deep venous thrombosis or pulmonary embolisms; overall, the scientific high-level literature evidence supports the safety of TXA for the different orthopaedic applications.

This is a 2-arm study aimed at comparing the Tranexamic Acid supplementation protocol and evaluating his advantages over routine protocols. The primary objective will be the effect on postoperative anaemia, detected by serial measurements of haemoglobin, of TXA supplementation for femoral shaft fractures surgery. The secondary objectives of the study will be the comparison between I.V. peri-operative TXA supplementation and normal protocol without TXA in terms of post-operative anaemia (detected by serial haematocrit measurements), intra-operative blood loss, post-operative blood loss, total blood loss (evaluated using the Hb balance formula, estimated blood loss, blood transfusion requirements, length of hospitalisation, cost-effectiveness and frequency of adverse events. In particular the study aims to assess safety of TXA and its tolerability in terms of incidence of venous thromboembolic complications, such as deep venous thrombosis or pulmonary embolisms, wound infection, and death. The safety of TXA supplementation protocol will be verified comparing to the no-treatment group in terms of incidence of complications, such as deep venous thrombosis (based on the Homan sign and Mose sign and confirmed by compression ultrasonography upon clinical suspicion), Pulmonary embolism (confirmed by spiral computed tomography), cerebrovascular accident (confirmed by computed tomographic scan or magnetic resonance imaging), and acute coronary syndrome or myocardial infarction (confirmed by troponin I estimation and electrocardiogram changes), infection, and death. This randomized control trial will thus define if the peri-operative protocol should be implemented with tranexamic acid to reduce post-operative anaemia and blood loss and the rate of blood transfusion leading to a better cost effectiveness, without an increase in adverse events.

The study presents only minimal risks for the included patients.

Study Type

Interventional

Phase

  • Phase 4

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute femoral shaft fracture.
  • Patients treated surgically with intramedullary nail or femoral plate
  • Patients aged 18-80 years old.
  • Patients with a BMI >18.5 and <35.
  • Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.
  • Informed Consent as documented by signature

Exclusion Criteria:

  • Pathological fracture or other lower limb fractures associated or multiple fractures.
  • Use of any anticoagulant at the time of admission (eg, vitamin K antagonists, anti-thrombin agents, antiplatelet agents or factor IIa and Xa inhibitors).
  • Contraindications to TXA (eg documented allergy to TXA).
  • Hepatic dysfunction (aspartate transaminase (AST)/alanine transaminase (ALT)>60 U/l) or renal dysfunction (Cr >1.5 mg/dl of glomerular filtration rate (GFR)>30 ml/min).
  • History of DVT or pulmonary embolus.
  • Active coronary artery disease or cerebrovascular accident (event in the past 12 months).
  • Coagulopathy based on admission laboratory values (international normalised ratio (INR)>1.4, partial thromboplastin time (PTT)>1.4× normal sec, platelets <50 000 per mm3)
  • Women who are pregnant or breast feeding.
  • Known or suspected non-compliance, drug or alcohol abuse.
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
  • Participation in another study with investigational drug within the 30 days preceding and during the present study.
  • Previous enrolment into the current study.
  • Enrolment of the investigator, his/her family members, employees and other dependent persons.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A: Tranexamic Acid group
Patients in the Tranexamic Acid (TXA) group (arm-A) will be administered with 2 doses of intravenous tranexamic acid (cumulative dose 10ml=1g) as follows: the first dose 10 minutes before the surgical incision (1 vial of 5 ml = 0,5g by slow intravenous injection(=1ml/minute)), and the second 3 hours after the start of surgery (1 vial of 5 ml = 0,5g, by slow intravenous injection).
Drug: Tranexamic Acid
Tranexamic Acid will be administered as an injectable solution (500mg/5ml or 1000mg/10ml).
Other Names:
  • TRANEXAM OrPha Inj Lös 500 mg/5ml
No Intervention: B : No treatment group
In the control group, will not be administered TXA or any other drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative anaemia
Time Frame: 3 days after surgery
Postoperative anaemia detected by daily measurements of haemoglobin in the first 3 days after surgery
3 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative anaemia
Time Frame: 3 days
Post-operative anaemia reported as changes in haemoglobin and haematocrit values during the first 3 days after surgery.
3 days
Intra-operative blood loss
Time Frame: Day 0
This outcome will be documented using a suction apparatus during the procedure. Blood collected in the suction bottle will be measured by subtracting the volume of saline used for wash.
Day 0
Post-operative blood loss at during the first 2 days after surgery
Time Frame: Up to day 2
This outcome will be documented using postoperative drain outputs. Blood collected in the drain outputs will be measured in milliliter at 24h and 48h
Up to day 2
Estimated total blood loss.
Time Frame: Up to day 2
This outcome will be documented using Hb balance formula.
Up to day 2
Estimated total blood loss.
Time Frame: Up to day 2
This outcome will be documented using Gross Formula.
Up to day 2
Blood transfusion requirements.
Time Frame: Up to day 2
This outcome will be documented in terms of number of patients who required packed red blood cell (PRBC) (transfusion rate) and the mean number of transfusion units per patient during all the length of hospitalization.
Up to day 2
Length of hospital stay
Time Frame: Up to week 2
Length of hospital stay
Up to week 2
Cost effectiveness of the treatment with tranexamic acid.
Time Frame: 1 week
This outcome will be documented reporting the mean cost per patient as sum of the cost TXA administration (if administered), the transfusion cost per patients, and the cost of hospital stay.
1 week

Collaborators and Investigators

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

Sponsor

Christian Candrian

Investigators

  • Principal Investigator: Christian Candrian, MD; Prof., EOC

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.

General Publications

Helpful Links

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 (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

September 1, 2026

Study Completion (Anticipated)

September 1, 2026

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORL - ORT - 023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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