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

Jaspreet Singh

Status and phase: Completed; Phase 4

Conditions: Lower Extremity Fracture; Trauma; Tranexamic Acid

Treatments: Drug: Tranexamic acid injection; Other: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04986813

PHMA/GSMCH-17/IEC-29A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups, including a placebo group

Group Tranexamic Acid

Active Comparator group

Description:

50 patients were given 1 gram of Tranexamic acid (TXA) intravenously pre-operatively. Intravenous TXA was administered, at the time of start of surgical incision.

Treatment:

Drug: Tranexamic acid injection

Control group

Placebo Comparator group

Description:

50 patients were kept as a control group and were not given TXA.

Treatment:

Other: Normal Saline