Topical Tranexamic Acid (TXA) in Hip Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hip Fracture Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tranexamic Acid Wash

Participants in the experimental arm will receive a wash of tranexamic acid topically at the site of surgery.

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Saline Wash

Participants in the control arm will receive a wash of saline topically at the site of surgery.

Group Type PLACEBO_COMPARATOR

Saline Wash

Intervention Type OTHER

Interventions

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Tranexamic Acid

Intervention Type DRUG

Saline Wash

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

1. 18 years of age or older
2. Diagnosis of hip fracture (Intracapsular, Intratrochanteric or Subtrochanteric) requiring surgical repair
3. Patient/surrogate decision maker provide signed informed consent

Exclusion Criteria

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

1. Patient has documented renal failure with glomerular filtration rate of \<30ml/min/1.73m2
2. Documented allergy to tranexamic acid
3. Current use of hormone replacement therapy
4. Acquired disturbances of colour vision
5. Refusal of blood products
6. Pre-operative use of anticoagulant therapy (Coumadin, heparin \< 5 days of surgery, fibrinolytic disorders requiring intraoperative anti-fibrinolytic treatment)
7. Coagulopathy (pre-operative platelet count \<150,000/mm3, International Normalized Ratio (INR) \>1.4, prolonged Partial Thromboplastin Time (PTT) \>1.4x normal)
8. Hematuria
9. Acute coronary syndrome within 6 weeks of fracture
10. Any history of venous thromboembolism
11. Any intraoperative surgical/medical/anesthetic complications i.e.: myocardial infarction or neurovascular injury occurring prior to application of the tranexamic acid
12. Pregnant or lactating
13. 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
14. Unable/unwilling to provide informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No