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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04986813
• Other study ID #: PHMA/GSMCH-17/IEC-29A
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: July 2021
• Source: AP Jain Civil Hospital, Rajpura
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Extremity Fracture
• Tranexamic Acid
• Trauma
• Wounds and Injuries

Intervention

Drug:
• Tranexamic acid injection
1 g of TXA in 100 ml of normal saline

Other:
• Normal Saline
100 ml

Locations

Country	Name	City	State
India	APJain Civil Hospital, Rajpura	Patiala	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Jaspreet Singh

Country where clinical trial is conducted

India, 

References & Publications (3)

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. Preho — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Requirement of number of units of blood transfusion	From the date of surgery till time of discharge	Average of 15 days
Secondary	Evidence of deep vein thrombosis by Wells Score	Based on Wells et al Clinical model for DVT	Average of 15 days (From the date of surgery till time of discharge)
Secondary	Change in Haemoglobin level post surgery	From the date of surgery till time of discharge	Average of 15 days (From the date of surgery till time of discharge)
Secondary	Number of days admitted in the hospital after surgery	From the date of admission till time of discharge	Average of 15 days (From the date of admission till time of discharge)