Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty

Study Overview
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Brief Summary
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A randomized, prospective, placebo-controlled study which aims to evaluate the effect of combined intraarticular and intravenous Tranexamic acid on total blood loss following unilateral knee replacement versus only intravenous tranexamic acid.

Detailed Description
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Intravenous (IV) Tranexamic acid is already well-established and well-documented regarding significant effect on reducing blood loss following knee replacement. A few studies more shown a similar effect of intraarticular (IA) injected Tranexamic acid into the knee joint at the end of surgery for knee replacement. In this study investigators therefore investigate the possible combined effect of added intraarticular tranexamic acid to conventional intravenous Tranexamic acid.

Official Title
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Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty - A Randomized, Prospective, Placebo-Controlled Study

Conditions
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Blood Loss, Postoperative Blood Loss, Thromboembolic Complications

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Saline water
* Drug: Tranexamic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years old Unilateral knee replacement Must be able to give oral and written consent Exclusion Criteria: General Anesthetized Allergic to Tranexamic acid In treatment with the following anticoagulants: Adenosine diphosphate receptor inhibitors or vitamin K antagonist within in the last 5 days. Factor Xa inhibitor and thrombin inhibitor. Use of oral anticonceptive. Reduced kidney function (S-creatinine > 120 micromol/L) Medicine or alcohol abuse Females with menstruation within the last 12 mounts. Any kind of cancer disease Rheumatoid arthritis Have participated in a clinical trial within the last 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IA Tranexamic acid + IV Tranexamic Acid<br>3 gram of Tranexamic acid diluted into 30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery. | Drug: Tranexamic Acid<br>* An anti-fibrinolytic drug injected into the knee joint at the end of surgery, 3 g diluted in 30 ml saline water.<br>* Other names: Cyclokapron;Drug: Tranexamic Acid<br>* An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups.<br>* Other names: Cyklocapron;|
| Placebo Comparator: IA Saline Water + IV tranexamic Acid<br>30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery. | Drug: Saline water<br>* 30 ml of Saline water injected into the knee capsula at the end of surgery.<br>* Other names: NaCl water;Drug: Tranexamic Acid<br>* An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups.<br>* Other names: Cyklocapron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total estimated blood loss |  | 24 hours surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total estimated blood loss |  | 2 days after surgery | 
| Thromboembolic complications | 90 days followup for thromboembolic complications. | 90 days postoperative | 
| Blood transfusion | Estimate the extent of blood transfusions during admission and readmission in relation to the knee replacement | while hospitalized expected 3 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic Acid, Knee Arthroplasty, Blood loss, Blood transfusion, Thrombolic complication, Total blood loss 24 h after ended surgery., Total blood loss 2 days after ended surgery.