Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
To find noninferiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss and serum concentration during primary total hip arthroplasty.

Detailed Description
-----------------
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
-----------------
Study of the Noninferiority of an Oral vs Intravenous Administration of Tranexamic Acid in Total Hip Arthroplasty

Conditions
-----------------
Hemorrhage Postoperative, Total Blood Loss, Arthroplasty Complications

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid Oral Product
* Drug: Tranexamic acid injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - ASA physical status 1, 2 and 3 scheduled for primary total hip arthroplasty 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
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Tranexamic Acid<br>128 patients scheduled for primary total hip arthroplasty | Drug: Tranexamic Acid Oral Product<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>|
| Active Comparator: Intravenous Tranexamic Acid<br>128 patients scheduled for primary total hip arthroplasty | Drug: Tranexamic acid injection<br>* Intravenous administration of 1 gramme tranexamic acid 30 minutes before skin incision and 1 gramme intravenous tranexamic acid 4 hours after first administration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total blood loss | Peroperative (suction) and postoperative (drainage) total blood loss | First 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of tranexamic acid | Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group | 2 hours after oral administration | 
| Serum concentration of tranexamic acid | Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group | 6 hours after oral administration | 
| Serum concentration of tranexamic acid | Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group | 30 minutes after intravenous administration | 
| Serum concentration of tranexamic acid | Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group | 4 hours after intravenous administration | 
| Serum hemoglobin variation | Variation of serum hemoglobin between preoperative and postoperative period | 24 hours after surgery | 
| Serum hemoglobin variation | Variation of serum hemoglobin between preoperative and postoperative period | 72 hours after surgery | 
| Incidence of blood transfusion | Incidence of blood transfusion in two groups | 72 hours after surgery | 
| Incidence of thromboembolic complications | Incidence of thromboembolic complications such as pulmonary embolism or deep venous thrombosis | 72 hours after surgery | 
| Length of hospitalisation stay | Difference between two groups of total hospitalisation days | 1 week after surgery |