Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Surgery Reduce Postoperative Haemarthrosis

Study Overview
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Brief Summary
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To find superiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss, haemarthrosis prevalence and improvement functional prognosis in anterior cruciate ligament arthroscopy.

Detailed Description
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Tranexamic acid is an anti-fibrinolytic drug, recommended in total hip arthroplasty to reduce peroperative and postoperative hemorrhagic complications. The original character of our study lies in the serum dosage of tranexamic acid, allowing to correlate the primary objective (blood loss) with this one. The investigators will focus on the reduction of the risks associated with the administration of intravenous medicines, the economic aspect and the ease of use.

Official Title
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Does Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Arthroscopic Surgery Reduce Postoperative Haemarthrosis and Improve Functional Prognosis?

Conditions
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Total Blood Loss, Hemorrhage Postoperative, Anterior Cruciate Ligament Rupture, Arthroscopy

Intervention / Treatment
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* Drug: Oral tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary arthroscopic surgery for anterior cruciate ligament reconstruction Exclusion Criteria: Renal failure with serum creatinine level higher than 1,40 mg/dL Thromboembolic events in last 12 months before surgery Pregnancy Congenital or acquired coagulation diseases History of gastric surgery that could lead to malabsorption Diabetic gastro-paresis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blinded prospective randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Tranexamic Acid<br>52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy | Drug: Oral tablet<br>* Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration<br>|
| Placebo Comparator: Placebo<br>52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy | Drug: Placebo<br>* Oral administration of lactose tablet (placebo)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of haemarthrosis | Postoperative (drainage) blood loss | First 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain score on numeric ratio scale (NRS) from 0 (no pain) to 10 (worst pain) | 24 hours after surgery | 
| Postoperative pain | Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain) | 72 hours after surgery | 
| Postoperative pain | Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain) | 7 days after surgery | 
| Postoperative pain | Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain) | 15 days after surgery | 
| Clinical evaluation of functional recovery | Tegner activity score from 0 (no activity) to 10 (competitive sport) | 1 days after surgery | 
| Clinical evaluation of functional recovery | Tegner activity score from 0 (no activity) to 10 (competitive sport) | 3 days after surgery | 
| Clinical evaluation of functional recovery | Tegner activity score from 0 (no activity) to 10 (competitive sport) | 7 days after surgery | 
| Clinical evaluation of functional recovery | Tegner activity score from 0 (no activity) to 10 (competitive sport) | 15 days after surgery | 
| Length of hospital stay | Total days of hospitalization | First 30 days after surgery |