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

Phase 4

Completed

• Conditions: Trauma; Lower Extremity Fracture; Tranexamic Acid
• Interventions: Drug: Tranexamic acid injection; Other: Normal Saline

• Registration Number: NCT04986813
• Lead Sponsor: Jaspreet Singh

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.

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 Timeline

• Study Start: 2017-04-01
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2021-07
• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-29
• Last Update Submitted: 2021-07-29
• Study First Posted: 2021-08-03
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Tranexamic Acid	Tranexamic acid injection	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.
Control group	Normal Saline	50 patients were kept as a control group and were not given TXA.

Primary Outcome Measures

Name	Time	Method
Requirement of number of units of blood transfusion	Average of 15 days	From the date of surgery till time of discharge

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

APJain Civil Hospital, Rajpura; 🇮🇳 Patiala, Punjab, India