To Evaluate the Efficacy of Tranexamic Acid to Reduce Operative Blood Loss

A Double Blinded Phase III Randomized Placebo Controlled Trial to Evaluate the Efficacy of Tranexamic Acid to Reduce Operative Blood Loss in Bone Tumor Patients - TraxBT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/018891

Enrollment

190

Registered

2019-05-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified Health Condition 2: null- Bone Tumor Patients

Interventions

Intervention1: Tranexamic acid: Medication (TXA) of 15 mg/kg dose will be mixed in 100 ml of normal saline without the knowledge of the operating team. Similar three infusion bottles will be prepared

Eligibility

Inclusion criteria

Inclusion criteria: All bone tumor patients (paediatric and adult patients) undergoing megaprosthetic replacement for proximal femur, distal femur, total femur, proximal tibia, and intercalary resection of femur will be included in this study.

Exclusion criteria

Exclusion criteria: 1) Patients with a known coagulopathy 2) Any contraindication / allergic to Tranexamic acid 3) Where antiplatelet agents could not be stopped 7 days prior to surgery 4) Revision prosthetic replacement surgeries. 5) History of deep vein thrombosis (DVT) or pulmonary embolism (PE) being treated with anticoagulation 6) Known congenital thrombophilia 7) History of cardiac stent or ischemic stroke 8) Renal impairment defined as Scr >1.5 or calculated CrCl 9) Severe ischemic heart disease (NYHA class III or higher) 10) History of thromboembolic or vascular disease. 11) Disseminated intravascular coagulation (DIC), other coagulopathy, INR > 1.4, platelet count 12) Liver dysfunction (Bilirubin > 1.5mg/dL, SGOT / SGPT > two times the upper limit of normal), history of chronic liver disease 13) History of seizures. 14) Subjects undergoing simultaneous vascular graft or reconstruction.

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of Tranexamic acid in reducing intra and post-operative blood loss(during first 48 hours) in bone tumour patients undergoing tumor resection as a part of limb salvage surgeriesTimepoint: first 48hrs post surgery	—

Secondary

Measure	Time frame
To assess the reduction in requirement of blood transfusion both intra-operative and during first 48 hours post surgery in both the arms. To assess 30 day morbidity in both arms. To assess the effect of extra osseous soft tissue mass and length of resection on intra and post-operative blood loss in both arms. Thromboembolic events Timepoint: first 48hrs post surgery 30 days morbidity	—

Countries

India

Contacts

Public ContactDr Ashish Gulia

Tata Memorial Centre

aashishgulia@gmail.com02224177000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026