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

July 29, 2021 updated by: Jaspreet Singh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Punjab
      • Patiala, Punjab, India, 140401
        • APJain Civil Hospital, Rajpura

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Requirement of number of units of blood transfusion
Time Frame: Average of 15 days
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
Time Frame: Average of 15 days (From the date of surgery till time of discharge)
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
Time Frame: Average of 15 days (From the date of surgery till time of discharge)
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
Time Frame: Average of 15 days (From the date of admission till time of discharge)
From the date of admission till time of discharge
Average of 15 days (From the date of admission till time of discharge)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaspreet Singh

Investigators

  • Study Director: Gurleen Kaur, MD, Adesh Medical College & Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHMA/GSMCH-17/IEC-29A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Trauma

Clinical Trials on Tranexamic acid injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe