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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial of a Hospital Policy of Tranexamic Acid Use to Reduce Transfusion in Major Non-cardiac Surgery

NCT04803747

Major Non-cardiac Surgeries

COMPLETED PHASE4

Effect of Early Administration of TXA in Adult Hip Fractures

NCT05047133

Postoperative Blood Loss

RECRUITING PHASE2/PHASE3

Tranexamic Acid in Intertrochanteric and Subtrochanteric Femur Fractures

NCT02580227

Hip Fractures Surgical Blood Loss

UNKNOWN PHASE4

Tranexamic Acid in Hip Fracture Surgery

NCT02736383

Hip Fracture

COMPLETED

Tranexamic Acid Versus Placebo for Blood to Reduce Perioperative Bleeding Post-liver Resection

NCT01651182

Cancer Tumour Surgery

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tranexamic Acid Trauma Lower Extremity Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This was a single centre, parallel group, prospective randomized control study.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

The random allocation of the patients to either group was done by one of the investigators using a random number table.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group Tranexamic Acid

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.

Group Type ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type DRUG

1 g of TXA in 100 ml of normal saline

Control group

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

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

100 ml

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tranexamic acid injection

1 g of TXA in 100 ml of normal saline

Intervention Type DRUG

Normal Saline

100 ml

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Inj Tranexa NS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No