Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery

Study Overview
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Brief Summary
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This study was done to evaluate the efficacy of Tranexamic Acid (TXA) in reducing blood transfusion requirement in patients of lower limb trauma undergoing surgery.

Detailed Description
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This was a single centre, parallel group, prospective randomized control study. 116 patients of lower limb trauma presented between April 2017 to August 2018 at Civil Hospital Rajpura. 16 patients were excluded due to old fracture, percutaneous wire fixation or non-consenting patient. The remaining 100 patients were randomized into two groups. 50 patients were given 1 gram of TXA before surgery and 50 patients were not given TXA. Fall in Hb, requirement of blood transfusion, number of days admitted in the hospital after surgery and evidence of deep vein thrombosis were monitored.

Official Title
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Efficacy of Tranexamic Acid in Reducing Requirement of Blood Transfusion in Lower Limb Trauma Surgery: A Prospective Randomized Controlled Study

Conditions
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Tranexamic Acid, Trauma, Lower Extremity Fracture

Intervention / Treatment
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* Drug: Tranexamic acid injection
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients suffering from lower limb trauma Exclusion Criteria: Presence of old implant or infection at the fracture site, Any blood coagulation disorder Patients undergoing percutaneous wire placement procedures for fracture fixation Polytrauma Non-consenting patients Psychiatric patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This was a single centre, parallel group, prospective randomized control study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Tranexamic Acid<br>50 patients were given 1 gram of Tranexamic acid (TXA) intravenously pre-operatively. Intravenous TXA was administered, at the time of start of surgical incision. | Drug: Tranexamic acid injection<br>* 1 g of TXA in 100 ml of normal saline<br>* Other names: Inj Tranexa;|
| Placebo Comparator: Control group<br>50 patients were kept as a control group and were not given TXA. | Other: Normal Saline<br>* 100 ml<br>* Other names: NS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Requirement of number of units of blood transfusion | From the date of surgery till time of discharge | Average of 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of deep vein thrombosis by Wells Score | Based on Wells et al Clinical model for DVT | Average of 15 days (From the date of surgery till time of discharge) | 
| Change in Haemoglobin level post surgery | From the date of surgery till time of discharge | Average of 15 days (From the date of surgery till time of discharge) | 
| Number of days admitted in the hospital after surgery | From the date of admission till time of discharge | Average of 15 days (From the date of admission till time of discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic acid, Deep Vein Thrombosis, Blood transfusion