Lower Extremity Fracture, Tranexamic Acid, Trauma
Conditions
Keywords
Tranexamic acid, Deep Vein Thrombosis, Blood transfusion
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.
Interventions
DRUGTranexamic acid injection
1 g of TXA in 100 ml of normal saline
OTHERNormal Saline
100 ml
Sponsors
Jaspreet Singh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
The random allocation of the patients to either group was done by one of the investigators using a random number table.
Intervention model description
This was a single centre, parallel group, prospective randomized control study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Requirement of number of units of blood transfusion | Average of 15 days | From the date of surgery till time of discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of deep vein thrombosis by Wells Score | Average of 15 days (From the date of surgery till time of discharge) | Based on Wells et al Clinical model for DVT |
| Change in Haemoglobin level post surgery | Average of 15 days (From the date of surgery till time of discharge) | 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) | From the date of admission till time of discharge |
Countries
India
Outcome results
None listed