CTRI/2023/11/059817尚未招募3 期
Pre-emptive transjugular intrahepatic portosystemic shunt versus optimized medical therapy in the management of acute variceal bleeding in patients with liver cirrhosis at high risk of rebleeding: A randomized controlled trial - nil
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. All patients with upper GI bleed originating from esophageal varices seen on endoscopy satisfying the following criteria
- •a) Child Class B (Score 7 and above) with active bleeding from the varices seen on endoscopy
- •b) Any patient belonging to Child Class C (score < 13)
- •2. Age between 18-65 years
- •3. Willing to participate in the study
排除标准
- •1. Failure to control bleed (primary hemostasis)
- •2. Patients belonging to Child Class A
- •3. Non-cirrhotic causes of portal hypertension
- •4. Hepatocellular carcinoma
- •5. Portal vein thrombosis/Portal cavernoma
- •6. Contraindications to beta-blockers- hypotension on beta blockers, uncontrolled asthma
- •7. Contraindications to TIPSS (provided in table below)
- •8. Active sepsis with or without septic shock
- •9. Underlying cardiopulmonary disease (ECHO)
- •10. Prior TIPSS
- •11. Chronic Kidney Disease or Acute Kidney Injury with serum creatinine >3.0 mg/dl
- •12. HE Grade 1 and above/or past history of recurrent HE ( >1 episode)
- •13. Pregnant women
- •14. Any underlying malignancy
- •15. Denied consent for participation
- •Contraindications to TIPSS
- •Ejection fraction <45 %
- •Uncontrolled sepsis or septic shock
- •Biliary malignancies
- •Severe pulmonary hypertension (mean pulmonary arterial pressures >40 mm of Hg)
- •Portal vein thrombosis
- •Platelets <20,000/cu.mm
研究者
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