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Completed

NCT Number: NCT02993341

Topical Tranexamic Acid (TXA) in Hip Fractures

Mechanisms by which to reduce exposure to allogeneic blood are of financial and clinical benefit in the hip fracture population. Tranexamic acid (TXA) is an inexpensive medication with low complication risk. Its use in the hip fracture population is unproven. The purpose of this study is to evaluate the efficacy and safety of topical tranexamic acid in reduction of peri-operative blood loss in hip fracture surgery.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sault Area Hospital

Sault Ste. Marie, Ontario, P6B0A8, Canada

About this study

The results of this study may dramatically alter the manner in which surgeons manage hip fracture patients in Canada. The use of topical TXA in operatively-treated hip fracture patients has the potential to reduce perioperative blood loss and consequently reduce exposure to allogeneic blood transfusion. This will positively influence post-operative morbidity and mortality, while at the same time substantially reduce hospital length of stay and overall health care costs. The proposed study is felt to have minimal risk, and is a relatively inexpensive study.

Update: An interim analysis was completed in January 2018. The Data Safety Monitoring Committee reviewed the results and recommend the trial continue as planned.

The final data analysis is in process. The abstract will be uploaded upon completion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All of the following criteria must be met to be eligible:

  • 18 years of age or older
  • Diagnosis of hip fracture (Intracapsular, Intratrochanteric or Subtrochanteric) requiring surgical repair
  • Patient/surrogate decision maker provide signed informed consent

Exclusion criteria

Participants cannot be included in this study if any of the following criteria apply:

  • Patient has documented renal failure with glomerular filtration rate of <30ml/min/1.73m2
  • Documented allergy to tranexamic acid
  • Current use of hormone replacement therapy
  • Acquired disturbances of colour vision
  • Refusal of blood products
  • Pre-operative use of anticoagulant therapy (Coumadin, heparin < 5 days of surgery, fibrinolytic disorders requiring intraoperative anti-fibrinolytic treatment)
  • Coagulopathy (pre-operative platelet count <150,000/mm3, International Normalized Ratio (INR) >1.4, prolonged Partial Thromboplastin Time (PTT) >1.4x normal)
  • Hematuria
  • Acute coronary syndrome within 6 weeks of fracture
  • Any history of venous thromboembolism
  • Any intraoperative surgical/medical/anesthetic complications i.e.: myocardial infarction or neurovascular injury occurring prior to application of the tranexamic acid
  • Pregnant or lactating
  • Any major medical or psychiatric disorder that in the opinion of the investigator, might prevent the subject from completely participating in the study or interfere with the interpretation of the study results
  • Unable/unwilling to provide informed consent

Treatment and study plan

Tranexamic Acid

Drug

Saline Wash

Other

Primary outcomes

  1. Change in hemoglobin

    Time frame: 1 day and 3 days post-surgery

    change in hemoglobin levels day 1 and 3 post-op compared to pre-op values and need for allogenic blood transfusion up to 3 days post-op

Secondary outcomes

  1. All-cause mortality

    Time frame: 30 days post-surgery

  2. Reduced risk of thrombotic event

    Time frame: 30 days post-surgery

    Measure incidence of venous thromboembolism (symptomatic ultrasound proven deep vein thrombosis or pulmonary embolism diagnosed by a ventilation-perfusion scan or computed tomography angiogram)

  3. Reduced peri-operative complications

    Time frame: 30 days post-surgery

    (post-operative surgical site infection, acute coronary syndrome, cerebrovascular event)

Sponsors and collaborators

Lead sponsor

Sault Area Hospital

Other

Registry information

Official study title

Topical Tranexamic Acid (TXA) in Hip Fractures, A Double-Blind, Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2019
First posted
Dec 15, 2016
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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