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
Verified date | July 2021 |
Source | AP Jain Civil Hospital, Rajpura |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
India | APJain Civil Hospital, Rajpura | Patiala | Punjab |
Lead Sponsor | Collaborator |
---|---|
Jaspreet Singh |
India,
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
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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