Topical Tranexamic Acid (TXA) in Hip Fractures

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993341
• Other study ID #: TXA-WASH-01
• Status: Completed
• Phase: Phase 3
• Start date: November 2016

Study information

• Verified date: August 2019
• Source: Sault Area Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. primary completion date: March 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Drug:
• Tranexamic Acid

Other:
• Saline Wash

Locations

Country	Name	City	State
Canada	Sault Area Hospital	Sault Ste. Marie	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sault Area Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause mortality		30 days post-surgery
Secondary	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
Secondary	Reduced peri-operative complications	(post-operative surgical site infection, acute coronary syndrome, cerebrovascular event)	30 days post-surgery