- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00985920
Topical Tranexamic Acid for Total Knee Arthroplasty
Efficacy of Intraoperative Topical Application of Tranexamic Acid in Reducing Perioperative Bleeding in Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Three million (1 in 10) Canadians suffer from Osteoarthritis (OA). Total knee arthroplasty (TKA), i.e. knee replacement surgery is the definitive treatment for knee osteoarthritis which alleviates pain and restores physical functioning. However, it can be associated with excessive postoperative bleeding leading to increased mortality and morbidity. The current blood conservation techniques, i.e. preoperative erythropoietin and autologous blood donation, do not reduce bleeding from the surgical site. As a result, many patients require blood transfusion with the associated risks and costs. In TKA, postoperative bleeding is attributed to diffuse microvascular bleeding as a result of increased fibrinolytic activity caused by releasing of the tourniquet which is routinely applied to provide appropriate surgical exposure during surgery. Therefore, tranexamic acid (TA), an antifibrinolytic agent which blocks the dissolution of hemostatic fibrin, can decrease blood loss following TKA. The systemic administration of TA, however, carries the risk of thromboembolic events such as deep vein thrombosis (DVT) or pulmonary embolism (PE). In TKA, this is of greater importance, as the patients are at higher risk of thromboembolic events. Topical application of TA in the surgical field is a cost-effective and simple route of administration that has been shown to reduce bleeding in dental, cardiac, and spine surgeries while minimizing systemic absorption and thromboembolism. Another major advantage of this approach is to prevent diffuse microvascular bleeding at the site of raw tissue surfaces resulting in decreased infection rate, pain, and increased range of motion (ROM) of the knee joints. In spite of these potential benefits, the innovative idea of topical application of TA has not been studied in TKA. However, if it is shown to be efficacious in decreasing postoperative bleeding, it can be incorporated into routine clinical practice with immediate beneficial impacts on patient care and quality of life.
Hypothesis:
In patients undergoing unilateral primary/revision TKA, intraoperative application of 1.5 g or 3 g topical TA into the surgical wound for five minutes before closure reduces perioperative bleeding as depicted by the maximal drop in systemic hemoglobin concentration during the postoperative period.
General Objective:
To study the role of tranexamic acid as a therapeutic tool, applied intraoperatively into the surgical wound, to reduce perioperative blood loss in patients undergoing a unilateral primary/revision TKA.
Specific Objectives:
To determine:
- the efficacy of topical application of TA to reduce perioperative transfusion requirements.
- the safety of topical application of TA (complications such as DVT).
- the systemic absorption of TA after topical application into the surgical wound.
- the impact of postoperative hemoglobin (Hb) reduction on patients' quality of life.
- the impact of topical application of TA on the length of hospital stay.
- the impact of topical application of TA on ROM, pain, and surgical infection rate of the knee joint.
- the incidence of autologous and allogenic blood transfusion in patients receiving the standard.
- multimodal blood conservation techniques for TKA surgery at our institution
- to compare the efficacy and safety of high dose (3 g) of TA versus low dose (1.5 g) of TA.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All adult patients (greater than 18 years old).
- Patients scheduled for primary unilateral total knee arthroplasty.
Exclusion Criteria:
- Allergy to tranexamic acid
- Acquired disturbances of color vision
- Preoperative anemia (hemoglobin <110 in females; hemoglobin <120 in males)
- Refusal of blood products (Jehovah's witnesses),
- Preoperative use of anticoagulant therapy - coumadin, heparin within 5 days of surgery, fibrinolytic disorders requiring intraoperative antifibrinolytic treatment,
- Coagulopathy (preoperative platelet count < 150,000/mm3, INR >1.4, prolonged PTT (>1.4 x normal))
- A previous history of thromboembolic disease (e.g. CVA, DVT or PE)
- Pregnancy
- Breastfeeding
- Significant co-morbidities:
- severe ischemic heart disease; NYHA Class III, IV,
- previous myocardial infarction
- severe pulmonary disease, e.g. FEV1<50% normal,
- plasma creatinine greater than 115 µmol/l in males and more than 100 µmol/l in females
- hepatic failure
- Intraoperative surgical/medical/anesthetic complications occur, e.g. MI, intraoperative bone fracture or neurovascular injury
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tranexamic acid, 1.5 g
1.5 g of tranexamic acid in 50 cc of normal saline solution is given to the patients.
|
Patients will receive a solution containing either 1.5g or 3 g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) or only 50 ml of saline without TA (placebo). The treatment solution will be prepared under sterile conditions and coded at TWH pharmacy. In the OR the sterile bag containing the solution will be given to the scrub nurse. The contents (50 ml) will be emptied in a sterile surgical bowl. TA or placebo solution (50 ml) will be then applied to the open joint and tissues by the bulb syringe and will be left in contact with the tissues for 5 minutes. Excess solution will be subsequently suctioned by placing the suction tip on the cemented component without touching the joint and surrounding tissues.
Other Names:
|
Experimental: Tranexamic acid, 3.0 g
3.0 g of tranexamic acid in 50 cc of normal saline is given to the patients.
|
Patients will receive a solution containing either 1.5g or 3 g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) or only 50 ml of saline without TA (placebo). The treatment solution will be prepared under sterile conditions and coded at TWH pharmacy. In the OR the sterile bag containing the solution will be given to the scrub nurse. The contents (50 ml) will be emptied in a sterile surgical bowl. TA or placebo solution (50 ml) will be then applied to the open joint and tissues by the bulb syringe and will be left in contact with the tissues for 5 minutes. Excess solution will be subsequently suctioned by placing the suction tip on the cemented component without touching the joint and surrounding tissues.
Other Names:
|
Placebo Comparator: Placebo, saline
50 cc of sterile normal saline solution is given to the patients.
|
Patients will receive a solution containing either 1.5g or 3 g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) or only 50 ml of saline without TA (placebo). The treatment solution will be prepared under sterile conditions and coded at TWH pharmacy. In the OR the sterile bag containing the solution will be given to the scrub nurse. The contents (50 ml) will be emptied in a sterile surgical bowl. TA or placebo solution (50 ml) will be then applied to the open joint and tissues by the bulb syringe and will be left in contact with the tissues for 5 minutes. Excess solution will be subsequently suctioned by placing the suction tip on the cemented component without touching the joint and surrounding tissues.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Calculated blood loss
Time Frame: Postoperative day 1-3
|
Postoperative day 1-3
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total prevalence of drug-related adverse events
Time Frame: one month after the medication/placebo administration
|
one month after the medication/placebo administration
|
perioperative packed red blood cell transfusion requirements
Time Frame: Intraoperative and postoperative day 1-3
|
Intraoperative and postoperative day 1-3
|
Systemic absorption of TA after topical application into the surgical wound
Time Frame: 1 hr after the surgey (after touniquet release)
|
1 hr after the surgey (after touniquet release)
|
length of hospital stay
Time Frame: postoperative
|
postoperative
|
The change in the knee joint range of motion at flexion
Time Frame: Postoperative day 2
|
Postoperative day 2
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The amount of pain at the knee joint measured by a visual scale (VAS)
Time Frame: Postoperative week 6
|
Postoperative week 6
|
Health-related quality of life determined by the Western Ontario and Mac Master Universities Osteoarthritis (WOMAC) index score
Time Frame: Postoperative week 6
|
Postoperative week 6
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jean Wong, MD, FRCPC, Staff Anesthesiologist , Assistant Professor, Department of Anesthesia, Toronto Western Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 070199A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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