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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04986813
Other study ID # PHMA/GSMCH-17/IEC-29A
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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)
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