Back to resultsTopical Tranexamic Acid (TXA) in Hip Fractures
Primary Purpose
Hip Fracture, Anemia
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Tranexamic Acid
Saline Wash
Sponsored by
About this trial
This is an interventional prevention trial for Hip Fracture
Eligibility Criteria
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
Sites / Locations
- Sault Area Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tranexamic Acid Wash
Saline Wash
Arm Description
Participants in the experimental arm will receive a wash of tranexamic acid topically at the site of surgery.
Participants in the control arm will receive a wash of saline topically at the site of surgery.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
All-cause mortality
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)
Reduced peri-operative complications
(post-operative surgical site infection, acute coronary syndrome, cerebrovascular event)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02993341
Brief Title
Topical Tranexamic Acid (TXA) in Hip Fractures
Official Title
Topical Tranexamic Acid (TXA) in Hip Fractures, A Double-Blind, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
March 5, 2019 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sault Area Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture, Anemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic Acid Wash
Arm Type
Experimental
Arm Description
Participants in the experimental arm will receive a wash of tranexamic acid topically at the site of surgery.
Arm Title
Saline Wash
Arm Type
Placebo Comparator
Arm Description
Participants in the control arm will receive a wash of saline topically at the site of surgery.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Type
Other
Intervention Name(s)
Saline Wash
Primary Outcome Measure Information:
Title
Change in hemoglobin
Description
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
Time Frame
1 day and 3 days post-surgery
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
30 days post-surgery
Title
Reduced risk of thrombotic event
Description
Measure incidence of venous thromboembolism (symptomatic ultrasound proven deep vein thrombosis or pulmonary embolism diagnosed by a ventilation-perfusion scan or computed tomography angiogram)
Time Frame
30 days post-surgery
Title
Reduced peri-operative complications
Description
(post-operative surgical site infection, acute coronary syndrome, cerebrovascular event)
Time Frame
30 days post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sault Area Hospital
City
Sault Ste. Marie
State/Province
Ontario
ZIP/Postal Code
P6B0A8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34388107
Citation
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.
Results Reference
derived
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Topical Tranexamic Acid (TXA) in Hip Fractures
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