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Completed

NCT Number: NCT04986813

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

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.

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Key information

Conditions

Tranexamic Acid Cardiovascular Diseases Embolism and Thrombosis Lower Extremity Fracture Thrombosis Trauma Vascular Diseases Venous Thrombosis Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

APJain Civil Hospital, Rajpura

Patiāla, Punjab, 140401, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic acid injection

Drug

1 g of TXA in 100 ml of normal saline

Other names: Inj Tranexa

Normal Saline

Other

100 ml

Other names: NS

Primary outcomes

  1. Requirement of number of units of blood transfusion

    Time frame: Average of 15 days

    From the date of surgery till time of discharge

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Jaspreet Singh

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 3, 2021
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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