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

Sponsor

Jaspreet Singh (Other)

Overall Status

Completed

CT.gov ID

NCT04986813

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Tranexamic Acid Trauma Lower Extremity Fracture	Drug: Tranexamic acid injection Other: Normal Saline	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This was a single centre, parallel group, prospective randomized control study.This was a single centre, parallel group, prospective randomized control study.

Masking:

Single (Participant)

Masking Description:

The random allocation of the patients to either group was done by one of the investigators using a random number table.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 1, 2017

Actual Primary Completion Date :

Aug 31, 2018

Actual Study Completion Date :

Aug 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group Tranexamic Acid 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 1 g of TXA in 100 ml of normal saline Other Names: Inj Tranexa
Placebo Comparator: Control group 50 patients were kept as a control group and were not given TXA.	Other: Normal Saline 100 ml Other Names: NS

Arm

Intervention/Treatment

Active Comparator: Group Tranexamic Acid

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

1 g of TXA in 100 ml of normal saline

Other Names:

Inj Tranexa

Placebo Comparator: Control group

50 patients were kept as a control group and were not given TXA.

Other: Normal Saline

100 ml

Other Names:

Outcome Measures

Primary Outcome Measures

Requirement of number of units of blood transfusion [Average of 15 days]
From the date of surgery till time of discharge

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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