Blood Loss After Early TXA in Hip Fractures.

Study Overview
=================
Brief Summary
-----------------
Our present study aims to initiate TXA administration immediately upon diagnosis of hip fracture in the Emergency Department. This will be a single blind randomized controlled trial comparing early administration of TXA in the ED in addition to perioperative dosing versus the standard perioperative administration only. The study population will include patients who have sustained a femoral neck, intertrochanteric, or subtrochanteric femur fracture and are undergoing surgical internal fixation or arthroplasty. We will prospectively compare the need for blood transfusion, total and hidden blood loss, postoperative complications, length of stay and readmission within 30 days.

Detailed Description
-----------------
Consent will be obtained for study enrollment from the patient or legal decision maker. The patient will then be randomized and stratified based on the fracture type, fixation method anticipated, and presence of anticoagulation. Treatment drug and saline placebo will be blinded from the patient. Treatment arm patients will receive a dose of 10 mg/kg of TXA IV as soon as possible in the ED. They will then receive repeat doses prior to skin incision and again after the end of surgery. Control group will receive a placebo dose of normal saline in the ED and then the standard 10 mg/kg TXA doses prior to surgery and again after the end of surgery. The perioperative doses will not be blinded.

Official Title
-----------------
The Effects of the Timing of Tranexamic Acid Administration on Blood Loss in Hip Fractures.

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Drug: Tranexamic acid
* Drug: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Femoral neck, intertrochanteric, subtrochanteric femur fracture Age >18 Undergoing surgical stabilization or arthroplasty by any method as determined by attending surgeon Exclusion Criteria: Age <18 Concomitant fracture Preoperative anemia needing blood transfusion before surgery Severe comorbidity (active cancer, severe pulmonary disease, ESRD) Allergy for tranexamic acid History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke, TIA) in the previous 12 months Myocardial infarction in the previous 12 months Renal function impairment (creatinine clearance <30 mL/min), or kidney transplant History of hypercoagulability (Factor V Leiden, Protein C/S deficiency)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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: Early TXA<br>Experimental group will receive 10 mg/kg IV TXA while in the Emergency Department, and repeat preoperative and postoperative doses. | Drug: Tranexamic acid<br>* 10 mg/kg IV TXA in the ED, repeat doses before skin incision and in PACU<br>* Other names: Early TXA;|
| Other: Control<br>Control group will receive 100 mL 0.9% normal saline in the Emergency Department, and 10 mg/kg IV TXA before skin incision and again in post anesthesia care unit. | Drug: Normal Saline<br>* 100 mL 0.9% normal saline in the ED, 10 mg/kg IV TXA before skin incision and in PACU<br>* Other names: Control Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in calculated and recorded hemoglobin | Change in hemoglobin (blood loss) will be assessed based on preoperative blood draw and blood draws post op and on each inpatient day during hospitalization. | From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first. | 
| Total postoperative units of red blood cell transfusion | The number of units of RBC transfusions will be recorded and compared between treatment and placebo groups. | From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VTE | DVT or PE | Postoperative for 30 days | 
| Infection | Superficial and deep infections | Postoperative for 30 days | 
| Readmission | 30 day readmission | Within 30 days postoperative | 
| Other complications | Any additional unforeseen complications | Postoperative for 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TXA, tranexamic acid, hip fracture