Topical Application of Tranexamic Acid Reduces Postoperative Blood Loss in Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted intravenously in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of topical use of tranexamic acid in reduction of blood loss and transfusions for total hip arthroplasty

Official Title
-----------------
Prospective Randomized Trial Comparing Topical Tranexamic Acid Plus Standard Of Care Versus Standard Of Care For The Reduction Of Blood Loss Following Primary Total Hip Arthroplasty Surgery

Conditions
-----------------
Hip Replacement, Postoperative Hemorrhage

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who are to undergo elective total hip arthroplasty. Must be primary arthroplasty. Must be single-side arthroplasty. Must be older than 18 years. Exclusion Criteria: Cemented arthroplasty. Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia . Patients with known coagulopathy (APTT or PT outside normal range pre-operatively). Patients who have a past medical history of thrombi-embolism at any time. Patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit <24%). Patients with documented DVT or PE at screening or in past three months. Patients having known hypersensitivity to tranexamic acid or any other. constituent of the product. Patients with any associated major illness (e.g., severe cardiac [New York Heart Association Class III or IV] or respiratory disease). Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week. Jehovah's Witnesses, or any other group of patients with ethical objections to receiving blood products.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid<br> | Drug: Tranexamic Acid<br>* 1 g Tranexamic Acid mixed with 100ml saline are kept in wound for 2 hours before drainage is opened postoperatively<br>|
| Placebo Comparator: control group<br> | Drug: normal saline<br>* 100ml saline is kept in wound for 2 hours before drainage is opened postoperatively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss as calculated from change in haematocrit |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative blood loss |  | 1 day | 
| Postoperative blood loss |  | postoperative 4 hours, 1 day, 2 days, 7days respectively | 
| Hemoglobin levels |  | postoperative 4 hours, 1 day, 2 days, 7days respectively | 
| drainage volume |  | postoperative 1 day, 2 days | 
| Proportion of patients receiving transfusions |  | 7 days | 
| Incidence of deep vein thrombosis postoperatively |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tranexamic Acid