Efficacy of Tranexamic Acid in Reducing Requirement of Blood Transfusion in Lower Limb Trauma Surgery: A Prospective Randomized Controlled Study
Phase: PHASE4
Conditions: Tranexamic Acid, Trauma, Lower Extremity Fracture
Sponsor: Jaspreet Singh

 
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Study Title:  
Efficacy of Tranexamic Acid in reducing requirement of blood transfusion 
in Lower Limb Trauma Surgery: A prospective randomized controlled study 
 
Date: 05th July, 2021 
 
 
 
 

 
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Study Protocol 
This study was a single-centre, randomized controlled parallel group study with 
1:1 allocation. After obtaining ethical approval from IEC (Ref No. PHMA/GSMCH-
17/IEC-29A), 116 patients of lower limb trauma presenting to Emergency 
Department of Civil Hospital, Rajpura between April 2017 to August 2018 were 
taken up for the study. Written informed consent was obtained from all the 
participating patients. 
Patient selection 
The patients, aged 18-60 years, suffering from lower limb trauma were taken up 
for the purpose of the study. The presence of old implant or infection at the 
fracture site, or any blood coagulation disorder were the exclusion criteria for the 
study. The patients undergoing percutaneous wire placement procedures for 
fracture fixation were also excluded from the study. The other exclusion criteria 
were polytrauma, non-consenting patients, psychiatric patient. 16 patients were 
excluded due to old fracture, percutaneous wire fixation or non-consenting 
patient. A total of 100 patients met the inclusion criteria and were enrolled. 
Pre-operative evaluation 
The enrolled patients were assessed preoperatively and all relevant 
investigations done. The patients were taken up for surgery after stabilization of 
the general condition. Pre-operative blood transfusion was done as required to 
have Hb level of at least 9.5mg/dl. 
Surgical intervention 

 
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The patients were administered spinal anaesthesia or general anaesthesia, 
depending on the anaesthetist’s discretion. The patients were treated by internal 
fixation of fracture by means of plates or interlocking nails. They were given 
antibiotic prophylaxis at the beginning of surgery. Intra-operatively, all the 
patients were given Ringer Lactate and intravenous colloid solution (Haemaccel) 
for volume replacement. 
The patients enrolled were randomly divided into 2 groups. The random allocation 
of the patients to either group was done by one of the authors using a random 
number table. Group Tranexamic Acid (Group A) had 50 patients who were given 
1 gram of TXA intravenously pre-operatively. IV TXA was administered, at the 
time of start of surgical incision, by mixing 1 g of TXA in 100 ml of normal saline. 
Control group (Group B) had 50 patients which were kept as a control group and 
were not given TXA.  
Post-operative evaluation 
The requirement of number of units of blood transfusion post- operatively was 
recorded as a primary outcome measure. The post-operative blood transfusion 
was done if the patients’ Hb level fell below 9.5 mg/dl. The secondary outcome 
measures included change in Haemoglobin level, total length of hospital stay and 
the evidence of deep vein thrombosis by Wells score. Patients of both groups 
were monitored by checking Haemoglobin (Hb) level as required. The Hb 
readings were expressed as mean ± Standard Deviation and range. 
Other complications were monitored daily by looking for leg swelling for DVT, 
breathlessness and fall in saturation for pulmonary embolism, or a cardiac event 

 
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like angina or myocardial infarction, deterioration of mental status for stroke 
event. In case the patient would have any of these complaints, a medical opinion 
was sought and managed accordingly. 
The probability of venous thromboembolism was suspected by use of Wells et al 
Clinical model to assess pre-test probability of DVT. Patients with a high 
probability were to be administered D-Dimer test and other relevant tests as 
needed to confirm thromboembolism.  
No prophylactic treatment for DVT was planned. All the patients were monitored 
for development of DVT and treatment to be given for symptomatic cases only. 
Renal function tests (RFTs) were done post surgery and at discharge. If the level 
of serum creatinine was elevated to above 1.4 mg/dl or the level of Blood Urea 
Nitrogen was higher than 25 mg/dl, then elevated RFT level was diagnosed and 
medical consultation was ordered. 
Sample size calculation 
Sample size was calculated based on a clinically significant effect with atleast 
25% reduction in need of blood transfusion in the post-operative period. 
Assuming requirement of blood transfusion in control and intervention group to 
be 15% and 40% respectively, with a two-sided significance of 0.05 and a power 
of 80%, a total of 49 patients in each group would be required. 
Statistical analysis 
Statistical analysis was performed using Microsoft Excel 2016. Quantitative data 
comparison between groups was analyzed using two-sample student t-test. The 
level of significance was set at p<0.05. 
 

 
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CONSORT 2010 Flow Diagram 
Assessed for eligibility (n=121) 
Excluded  (n= 21) 
♦   Not meeting inclusion criteria (n=5) 
♦   Declined to participate (n= 9) 
♦   Other reasons (n= 7) 
Analysed  (n=50) 
♦ Excluded from analysis (give reasons) (n=0) 
Lost to follow-up (give reasons) (n=0) 
Discontinued intervention (give reasons) (n=0) 
Allocated to intervention (n=50) 
♦ Received allocated intervention (n=50 ) 
♦ Did not receive allocated intervention (give 
reasons) (n=0 ) 
Lost to follow-up (give reasons) (n=0) 
Discontinued intervention (give reasons) (n=0)
Allocated to intervention (n= 50) 
♦ Received allocated intervention (n=50 ) 
♦ Did not receive allocated intervention (give 
reasons) (n=0) 
Analysed  (n=50) 
♦ Excluded from analysis (give reasons) (n=0) 
 
Allocation 
Analysis 
Follow-Up 
Randomized (n=100) 
Enrollment