Tranexamic Acid in Chinese Elderly Patients With Intertrochanteric Fracture RCT

Study Overview
=================
Brief Summary
-----------------
Hip fracture posed a major challenge to the health care system, with the one-year mortality of hip fracture reported as being approximately 20%. Perioperative haemoglobin level was associated with functional level of the patient and even mortality. Different methods for administration of tranexamic acid had been described. It was well established that systemic administration of tranexamic acid could reduce perioperative blood loss and transfusion rate. Topical administration had been shown to decrease blood loss and transfusion rate. The objective of our study is to investigate the hypothesis that tranexamic acid will reduce blood loss and transfusion rate in elderly patients undergoing hip fracture surgery.

Detailed Description
-----------------
The incidence of geriatric hip fractures is projected to increase by more than 250% in the next twenty-five years as the world population ages. Hip fracture in elderly patients are associated with significant morbidity and mortality. One of the significant morbidity is blood loss, which has been reported as high as 1500ml. Blood loss may lead subsequent blood transfusion. The rate of blood transfusion has been reported between 20 to 60%. Blood loss and subsequent blood transfusion could lengthen the overall hospital length of stay and delay the rehabilitation. Tranexamic acid, one of antifibrinolytic agents, is a synthetic derivative of the amino acid lysine and acts as a competitive inhibitor in the activation of plasminogen to plasmin, therefore preventing the degradation of fibrin. Shakur et al. reported that the use could reduce mortality in trauma patients. Tranexamic acid has been widely used in elective orthopaedic surgery such as total joint replacement and spine surgery. Several authors reported that tranexamic acid could decreases the blood loss, transfusion rate and cost.

Official Title
-----------------
The Use of Tranexamic Acid in Chinese Elderly Patients Undergoing Femoral Nailing for Intertrochanteric Fracture: A Randomized Controlled Trial

Conditions
-----------------
Fracture of Femur

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over the age of 60 Acute isolated intertrochanteric fracture and sub trochanteric fracture treated with short proximal femoral nailing Exclusion Criteria: Use of any anticoagulant at the time of admission Documented allergy to tranexamic acid History of pulmonary embolism or deep vein thrombosis Hepatic failure Severe renal insufficiency Active coronary artery disease in the past 12 months History of cerebrovascular accident in the past 12 months Presence of a drug-eluting stent Active oncological diseases Coagulopathy (international normalised ratio (INR)>1.4) Pathological fractures Periprosthetic fractures Operation >2 days from admission

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Local administration of tranexamic acid<br>All patients hip fracture will be treated according to the hospital standard procedure Check complete blood count on admission and Day 3 post-operation. 10ml tranexamic acid injected under the deep fascia around the fracture site under x-ray control Sealed envelope system: Operation room nurse will open a sealed envelope for treatment allocation. The medications are prepared by the nurse according to the instruction inside the envelop. Transfusion when clinically indicated or Hb < 8g/dL Blood Loss calculation (formula of Nadler, Hidalgo and Bloch) Blood taken at Day 3 post-operation will be used for measure of postoperative haematocrit. By this time postoperatively fluid shift has settled and the patient is haemodynamically stable. After discharge, patients will be seen in 6 weeks and 3 months | Drug: Tranexamic Acid<br>* The recruited patients will be randomly assigned to two groups, 50% chance to the experimental group (use of tranexamic acid) and 50% chance to the control group (use of normal saline). After the reduction of the intertrochanteric fracture, 10ml of tranexamic acid is injected under the deep fascia around the fracture area before inserting a drain. As for the control group, 10ml of normal saline is injected instead. Blood will be taken on the third day post operation, and the patient will be seen at 6 weeks, and 3 months.<br>* Other names: Transamin;|
| No Intervention: Control group<br>All patients hip fracture will be treated according to the hospital standard procedure Check complete blood count on admission and Day 3 post-operation. 10ml normal saline injected under the deep fascia around the fracture site under x-ray control Sealed envelope system: Operation room nurse will open a sealed envelope for treatment allocation. The medications are prepared by the nurse according to the instruction inside the envelop. Transfusion when clinically indicated or Hb < 8g/dL Blood Loss calculation (formula of Nadler, Hidalgo and Bloch) Blood taken at Day 3 post-operation will be used for measure of postoperative haematocrit. By this time postoperatively fluid shift has settled and the patient is haemodynamically stable. After discharge, patients will be seen in 6 weeks and 3 months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion rate | The total blood transfusion post operation | Day 3 post operation | 
| Blood loss | Blood loss calculation according to formula of Nadler, Hidalgo and Bloch | Day 3 post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 months mortality rate | mortality rate of the patient within post operation 3 months | from post operation to 3 months | 
| Complications | Complications related to thrombotic events | from post operation to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, intertrochanteric fracture