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临床试验/CTRI/2025/08/093022
CTRI/2025/08/093022尚未招募不适用

A prospective observational study on peri-operative management strategies and outcomes in patients on anti-platelet therapy in elective major non cardiac surgery

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
To observe the number of patients on antiplatelet therapy undergoing major elective non cardiac surgery and their peri operative modifications in management.

研究概览

简要总结

Coronary artery disease is the most common heart disease in Indian population. On an average every 1 in 20 adults of age 20 and above suffer from coronary artery disease at various levels of progression. About a quarter (24.8%) of deaths in India in 2010 were attributable to cardiovascular diseases. About 60,000 patients on an average in a year undergo CABG surgery in India. (1) About 5.5 lakh stents are being utilized annually in India on an average. (2)

Patients undergo one of the three paths in the management of coronary heart disease/high risk paitents based on complex scoring systems. Firstly, in patients who have significant comorbidities and have stable angina are medically managed with anti-platelet therapy, anti-anginal drugs, risk factor control and lifestyle modifications. Patients who have unstable angina, NSTEMI usually undergo a risk stratification using SYNTAX scoring and multi-disciplinary discussion among the cardiac team in hospitals and either undergo a CABG procedure or a PCI. Patients who have an Acute Coronary Syndrome come in an emergency situation and undergo PCI procedure.

Having said that, the anaesthetic implications of such patients in an elective non-cardiac surgery are huge and need to be dealt with great consideration. The risk-benefit consideration starts from the surgery OPD, then in PAC clinic and then one day prior to taking the patient on OT table.

We are conducting this study to know the number of patients on anti-platelet therapy, indication for starting them and other procedures they may have undergone. We will be also be recording the peri-operative outcomes of these patients using RCRI scores and post operative MACE.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 95.00 Year(s)(—)
性别
All

入选标准

  • All patients undergoing major surgery in main OTs in TMH under anaesthesia on anti platelet therapy.

排除标准

  • Patients undergoing procedures in any other locations like minor OTs, IR, MRI suites, etc.

结局指标

主要结局

To observe the number of patients on antiplatelet therapy undergoing major elective non cardiac surgery and their peri operative modifications in management.

时间窗: 6 hours post op- MI and arrhythmias | 24 hours post op- MACE | 72 hours post op- Stroke

次要结局

  • 1. To record the number of patients referred to other centres, from surgical OPD without referring to TMH PAC and record their outcome.(2. To note the number of patients referred to other centres or advised alternate modality from PAC in TMH after discussion in HRJCs.)
  • 4. To record perioperative blood loss and requirement for transfusion(5. To record perioperative hemodynamic instability requiring vasopressor/inotrope supports)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Vijaya Patil

Tata Memorial Hospital

研究点 (1)

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