NCT04986813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
Last Updated

August 3, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

July 5, 2021

Last Update Submit

July 29, 2021

Conditions

Tranexamic AcidTraumaLower Extremity Fracture

Keywords

Tranexamic acidDeep Vein ThrombosisBlood transfusion

Outcome Measures

Primary Outcomes (1)

  • Requirement of number of units of blood transfusion

    From the date of surgery till time of discharge

    Average of 15 days

Secondary Outcomes (3)

  • Evidence of deep vein thrombosis by Wells Score

    Average of 15 days (From the date of surgery till time of discharge)

  • Change in Haemoglobin level post surgery

    Average of 15 days (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)

Study Arms (2)

Group Tranexamic Acid

ACTIVE COMPARATOR

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

Control group

PLACEBO COMPARATOR

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

Other: Normal Saline

Interventions

Tranexamic acid injectionDRUG

1 g of TXA in 100 ml of normal saline

Also known as: Inj Tranexa
Group Tranexamic Acid
Normal SalineOTHER

100 ml

Also known as: NS
Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients suffering from lower limb trauma

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APJain Civil Hospital, Rajpura

Patiāla, Punjab, 140401, India

Location

Related Publications (3)

  • Kaye JA, Jick H. Epidemiology of lower limb fractures in general practice in the United Kingdom. Inj Prev. 2004 Dec;10(6):368-74. doi: 10.1136/ip.2004.005843.

    PMID: 15583259BACKGROUND

  • Zhang P, Bai J, He J, Liang Y, Chen P, Wang J. A systematic review of tranexamic acid usage in patients undergoing femoral fracture surgery. Clin Interv Aging. 2018 Sep 4;13:1579-1591. doi: 10.2147/CIA.S163950. eCollection 2018.

    PMID: 30233155RESULT

  • Fischer PE, Bulger EM, Perina DG, Delbridge TR, Gestring ML, Fallat ME, Shatz DV, Doucet J, Levy M, Stuke L, Zietlow SP, Goodloe JM, VanderKolk WE, Fox AD, Sanddal ND. Guidance Document for the Prehospital Use of Tranexamic Acid in Injured Patients. Prehosp Emerg Care. 2016 Sep-Oct;20(5):557-9. doi: 10.3109/10903127.2016.1142628. Epub 2016 Mar 17.

    PMID: 26985786RESULT

MeSH Terms

Conditions

Wounds and InjuriesVenous Thrombosis

Interventions

Tranexamic AcidSaline Solution

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Gurleen Kaur, MD

    Adesh Medical College & Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The random allocation of the patients to either group was done by one of the investigators using a random number table.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This was a single centre, parallel group, prospective randomized control study.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist Medical Officer

Study Record Dates

First Submitted

July 5, 2021

First Posted

August 3, 2021

Study Start

April 1, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

August 3, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)