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Secondary Prophylaxis Gastric Variceal Bleed

NCT00888784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2009-04-28

No results posted yet for this study

Summary

The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal (GOV2 or IGV1) rebleeding and improvement in survival.

Conditions

  • Cirrhosis

Interventions

PROCEDURE

Endoscopic Cyanoacrylate injection

Endoscopic Cyanoacrylate injection in gastric varix

DRUG

beta-blocker (propranolol)

Propranolol was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was \>90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure \<90 mm Hg or pulse rate \<55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.

Sponsors & Collaborators

  • Govind Ballabh Pant Hospital

    lead OTHER_GOV

Principal Investigators

  • Shiv K Sarin, MD, DM · Director, G B Pant Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00888784 on ClinicalTrials.gov