A scientific clinical trial to study the effect of medicine namely Tranexamic Acid versus normal saline in reducing blood loss during brain surgery among patients diagnosed with brain tumours.

Phase 3

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2024/05/066769
• Lead Sponsor: Basavatarakam Indo American Cancer Hospital and Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

All patients aged 18-65 years with the diagnosis of a Supratentorial brain tumour planned for undergoing Craniotomy and decompression are to be recruited

Exclusion Criteria

1. Allergy to tranexamic acid

2. Known Arterial or venous Thromboembolism

3. Known Coagulopathy- Altered PT, INR, aPTT

4. Use of Antiplatelet therapy or antocoagulant therapy

5. Significant Kidney (CKD 3-5) or Liver Disease (Child Pugh B, C).

6. Pregnant and Lactating Mothers

7. Patient Refusal to participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Blood LossTimepoint: 1. Blood loss during surgery is measured by the anaestheiologist . <br/ ><br>2. Post operative hemoglobin and hematocrit will be measured on post operative day 2 and 5

Secondary Outcome Measures

Name	Time	Method
1. Inraoperative surgical site assessment and Surgeons satisfaction. <br/ ><br>2. Reduction in blood transfusion <br/ ><br>3. Development of Deep vein ThrombosisTimepoint: 1. Intraoperative surgical site assessment, surgeons satisfaction and documentation of Boezaart score. <br/ ><br>2.PT,INR will be measured on Post operative day 1. <br/ ><br>3. Preoperative and post opeartive day 5 and 30 for Deep Vein Thrombosis screening will be done. <br/ ><br>4. The indication, quantity and time of blood transfusion will be documented