NCT03584087

Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After EVL

Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After Endoscopic Variceal Ligation: A Randomised Controlled Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Upper gastrointestinal (UGI) bleed of variceal origin is a common medical emergency. Prompt endoscopic variceal ligation (EVL) is therapeutic as well as diagnostic. Terlipressin, a vasopressin analog (intravenous, 2 mg q 4 hourly), is widely used promptly in any suspicious case of variceal haemorrhage (VH) before endoscopic procedure, along with volume and blood resuscitative measures. As per guideline, after EVL Terlipressin therapy (1 mg IV q 4 hourly) is continued for 2-5 day to prevent re-bleed. But the prolong use of Terlipressin is not completely safe as well as it is expensive also in resource constraint setting. At present there is no clinical trial available to prove the efficacy of post-EVL Terlipressin therapy in preventing re-bleed and mortality in cases of acute variceal haemorrhage. During the post marketing surveillance Terlipressin therapy has been found to be associated with life threatening complication like cardiac arrhythmia, myocardial ischemia, critical vasoconstriction of peripheral as well as internal organ leading to ischemia or gangrene, severe hyponatremia, hypertension, fluid overload and pulmonary oedema. So the justification of continuing Terlipressin therapy for 5 days after EVL is questionable, as haemostasis is primarily achieved by EVL and the risk versus benefit of Terlipressin therapy after EVL is still unknown. Continue IV Terlipressin therapy also prolongs in-hospital care causing further increase of health care burden. There is still lack of data of Terlipressin therapy, regarding its efficacy in preventing post-EVL re-bleed, mortality, adverse drug events and cost effectiveness. The investigator will study to evaluate the utility of Terlipressin therapy after EVL, in acute variceal haemorrhage.

Conditions

• Acute Variceal Haemorrhage

Interventions

Type	Name	Description
DRUG	Normal Saline	TG 0 (0Hr)
DRUG	Terlipressin	Duration of Terlipressin after EVL

Timeline

• Start date: 2018-05-07
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2018-07-12
• Last updated: 2019-12-16

Locations

1 site across 1 country: India