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

Phase 3

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

Registration Number: CTRI/2019/05/018891

Lead Sponsor: Tata Memorial Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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 <50 mL/min

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 <100000

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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