A Randomized Controlled Trial to Assess the Role of Emergent vs Early Endoscopy in Child B and C Cirrhotic Patients With Acute Variceal Bleed (AVB)-EARLY - AVB
Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Jan 15, 2025
Trial Information
Current as of July 12, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial, called the EARLY-AVB trial, is studying the best timing for a procedure called endoscopy in patients with cirrhosis who experience acute variceal bleeding (AVB), which is heavy bleeding from swollen blood vessels in the esophagus or stomach. The researchers want to see if doing the endoscopy urgently (within 4 hours) is more effective in reducing the risk of death compared to doing it early (within 4 to 12 hours) after a patient arrives at the hospital. This is important because patients with more severe liver disease (known as Child B and C cirrhosis) have higher rates of rebleeding and complications.
To participate in this trial, patients must be between 18 and 75 years old, have a diagnosis of Child B or C cirrhosis, and show a good response to fluid treatment within one hour of starting care. Unfortunately, patients with certain conditions, like those on blood thinners or with severe heart or lung diseases, cannot join the trial. If eligible, participants can expect to be closely monitored and receive early treatment to help control their bleeding. This research aims to improve care and outcomes for patients facing this serious health issue.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Child B and C cirrhotic patients with history of AVB
- • 2. \>18YRS and \<75 yrs.
- • 3. Fluid responsive within 1 hour after resuscitation
- Exclusion Criteria:
- • 1. EHPVO / NCPH
- • 2. Lack of consent Pregnancy
- • 3. Child A cirrhotics
- • 4. Severe cardiopulmonary disease requiring optimization (Deemed contraindication for endoscopy within 12 hours).
- • 5. Need of Dual vasopressors at presentation In Hospital patients with Bleed
- • 6. HCC patients with AVB
- • 7. Patients presented with AVB on going antiplatelets/anticoagulants.
About Institute Of Liver And Biliary Sciences, India
The Institute of Liver and Biliary Sciences (ILBS) in India is a premier research and healthcare institution dedicated to the advancement of knowledge and treatment in liver, biliary, and related diseases. As a clinical trial sponsor, ILBS is committed to conducting innovative and ethically-driven research to improve patient outcomes and enhance therapeutic options in hepatology. The institute fosters collaboration among multidisciplinary teams of clinicians, researchers, and healthcare professionals, ensuring rigorous scientific methodologies and adherence to regulatory standards. Through its focus on translational research, ILBS aims to bridge the gap between laboratory discoveries and clinical applications, ultimately contributing to the global understanding and management of liver diseases.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Delhi, Delhi, India
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported