Topical Tranexamic Acid (TXA) in Hip Fractures

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Hip Fracture
• Intervention / Treatment: Drug: Tranexamic Acid; Other: Saline Wash

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Sault Ste. Marie, Ontario, Canada, P6B0A8
      • Sault Area Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic Acid Wash; Participants in the experimental arm will receive a wash of tranexamic acid topically at the site of surgery.	Drug: Tranexamic Acid
Placebo Comparator: Saline Wash; Participants in the control arm will receive a wash of saline topically at the site of surgery.	Other: Saline Wash

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemoglobin	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	1 day and 3 days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		30 days post-surgery
Reduced risk of thrombotic event	Measure incidence of venous thromboembolism (symptomatic ultrasound proven deep vein thrombosis or pulmonary embolism diagnosed by a ventilation-perfusion scan or computed tomography angiogram)	30 days post-surgery
Reduced peri-operative complications	(post-operative surgical site infection, acute coronary syndrome, cerebrovascular event)	30 days post-surgery

Collaborators and Investigators

• Sponsor: Sault Area Hospital

Publications and helpful links

General Publications

• Costain D, Elder G, Fraser B, Slagel B, Kelly A, Cheong Y, Fera L. Topical tranexamic acid in hip fractures: a randomized, placebo-controlled double-blinded study. Can J Surg. 2021 Aug 10;64(4):E449-E456. doi: 10.1503/cjs.014220. Epub 2021 Aug 1.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): March 5, 2019

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 15, 2016

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TXA-WASH-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO