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临床试验/CTRI/2024/05/066769
CTRI/2024/05/066769尚未招募3 期

Effect of Tranexamic acid on the reduction of blood loss in Neuro Oncosurgical patients A Randomized control study

Basavatarakam Indo American Cancer Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月14日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Reduction in Blood Loss

研究概览

简要总结

Tranexamic acid (TXA) is a anti fibrinolytic agent that has been shown to reduce bleeding and blood transfusions in a variety of surgical disciplines. In neuro-onco-surgeries, significant blood loss requiring blood transfusion can occur in the perioperative period. However, there are few studies evaluating the use and challenges of Tranexamic acid in neuro-onco-surgeries, where significant blood loss can occur and perioperative thromboprophylaxis can be challenging. In this study we assess the effect of tranexamic acid in the reduction of blood loss. We also attempt to assess the need for blood transfusions, incidence of deep vein thrombosis and surgeon’s satisfaction about intraoperative bleeding.

Significance of study:

This study will assess the effect of tranexamic acid in reducing blood loss and blood transfusion, and development of deep vein thrombosis in oncological patients undergoing neurosurgery. This will help in reducing the blood transfusion requirements and load in the blood bank in our hospital.

Methodology

For all patients, pre anaesthetic checkup will be done as per department protocol. Patients with demographic data, namely age, weight, height, details of the size and type of tumour from the CT scan are collected. On the day of surgery, haemoglobin will be collected. Screening of deep vein thrombosis will be done by one of the primary investigators with Colour Doppler imaging and compression ultrasound to assess proximal and distal lower limb veins in pre op holding area.

Before induction, patients will be randomised by computer generated numbers into two groups

Group A Patients receiving Tranexamic acid 20 mg per kg actual body weight (diluted in 50 ml Normal saline at 150 ml/hour) over 20 minutes  + 1 mg/kg/hour (20 mg per kg of Tranexamic acid diluted in 50 ml of Normal saline at 2.5 ml per hour) infused till the completion of surgery.

Group B Patients receiving saline 150 ml per hour for 20 minutes + 2.5 ml per hour infusion till the completion of surgery.

Intraoperatively, arterial blood gases will be done at the discretion of the anaesthesiologist. Blood loss will be estimated based on collection in the suction bottle and soakage of mops and pads by the anaesthesiologist who will be unaware of the treatment group of the patient. . Blood will be transfused if Hb< 8 gm%, in cardiac patients if haemoglobin is between 8 to 10 g%, otherwise unexplained tachycardia or high vasopressor support. The use of Abgel and surgicel will be noted. At the end of the surgery, the satisfaction of the surgeon will be evaluated and documented by the Boezaart score for intraoperative surgical field.

Post operative haemoglobin and haematocrit will be measured on post operative day 2 and 5.

In ICU, mechanical thromboprophylaxis will be provided to all patients. No low molecular weight heparin will be administered as per hospital policy. Screening for deep vein thrombosis as done in the pre operative period will be done on day 5 and 1 month after surgery by the primary investigator who will be blinded to the allocation of the patient. Length of hospital stay will also be documented. Neurological improvement will be assessed based on the Glasgow outcome scale on post operative day 5 and post operative day 30. Any other complications occurring during hospital stay will be documented.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • Allergy to tranexamic acid
  • Known Arterial or venous Thromboembolism
  • Known Coagulopathy- Altered PT, INR, aPTT
  • Use of Antiplatelet therapy or antocoagulant therapy
  • Significant Kidney (CKD 3-5) or Liver Disease (Child Pugh B, C).
  • Pregnant and Lactating Mothers
  • Patient Refusal to participate.

结局指标

主要结局

Reduction in Blood Loss

时间窗: 1. Blood loss during surgery is measured by the anaestheiologist . | 2. Post operative hemoglobin and hematocrit will be measured on post operative day 2 and 5

次要结局

  • 1. Inraoperative surgical site assessment and Surgeons satisfaction.(2. Reduction in blood transfusion)

研究者

发起方
Basavatarakam Indo American Cancer Hospital and Research Institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

M Asiel Christopher

Basavatarakam IndoAmerican Cancer Hospital and Research Institute

研究点 (1)

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