Clinical trial NCT04986813: Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery
Official title: Efficacy of Tranexamic Acid in Reducing Requirement of Blood Transfusion in Lower Limb Trauma Surgery: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tranexamic Acid
Trauma
Lower Extremity Fracture
Keywords: Tranexamic acid
Deep Vein Thrombosis
Blood transfusion
Lead sponsor: AP Jain Civil Hospital, Rajpura
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a single centre, parallel group, prospective randomized control study.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Requirement of number of units of blood transfusion
timeFrame: Average of 15 days
Secondary outcomes:
measure: Evidence of deep vein thrombosis by Wells Score
timeFrame: Average of 15 days (From the date of surgery till time of discharge)
measure: Change in Haemoglobin level post surgery
timeFrame: Average of 15 days (From the date of surgery till time of discharge)
measure: Number of days admitted in the hospital after surgery
timeFrame: Average of 15 days (From the date of admission till time of discharge)
Other outcomes:
Locations:
city: Patiala
country: India
facility: APJain Civil Hospital, Rajpura
state: Punjab
Study officials:
affiliation: Adesh Medical College & Hospital
name: Gurleen Kaur, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.