Topical Tranexamic Acid (TXA) in Hip Fractures
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ClinicalTrials.gov Identifier: NCT02993341 |
Recruitment Status :
Completed
First Posted : December 15, 2016
Last Update Posted : August 19, 2019
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Condition or disease | Intervention/treatment | Phase |
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Hip Fracture Anemia | Drug: Tranexamic Acid Other: Saline Wash | Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Topical Tranexamic Acid (TXA) in Hip Fractures, A Double-Blind, Randomized Controlled Trial |
Study Start Date : | November 2016 |
Actual Primary Completion Date : | March 5, 2019 |

Arm | Intervention/treatment |
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Experimental: Tranexamic Acid Wash
Participants in the experimental arm will receive a wash of tranexamic acid topically at the site of surgery.
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Drug: Tranexamic Acid |
Placebo Comparator: Saline Wash
Participants in the control arm will receive a wash of saline topically at the site of surgery.
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Other: Saline Wash |
- 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
- All-cause mortality [ Time Frame: 30 days post-surgery ]
- 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)
- Reduced peri-operative complications [ Time Frame: 30 days post-surgery ](post-operative surgical site infection, acute coronary syndrome, cerebrovascular event)

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993341
Canada, Ontario | |
Sault Area Hospital | |
Sault Ste. Marie, Ontario, Canada, P6B0A8 |
Responsible Party: | Sault Area Hospital |
ClinicalTrials.gov Identifier: | NCT02993341 |
Other Study ID Numbers: |
TXA-WASH-01 |
First Posted: | December 15, 2016 Key Record Dates |
Last Update Posted: | August 19, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Fractures, Bone Hip Fractures Wounds and Injuries Femoral Fractures Hip Injuries Leg Injuries |
Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |