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Topical Tranexamic Acid (TXA) in Hip Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02993341
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Sault Area Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hip Fracture Anemia Drug: Tranexamic Acid Other: Saline Wash Phase 3

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Sault Area Hospital
Sault Ste. Marie, Ontario, Canada, P6B0A8
Sponsors and Collaborators
Sault Area Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Additional relevant MeSH terms:
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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