Clinical trial NCT03584087: Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After EVL
Official title: Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After Endoscopic Variceal Ligation: A Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Variceal Haemorrhage
Keywords: Terlipressin, Variceal Haemorrhage, EVL
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2018-07-12
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Irrespective of gender with age ≥ 18 years
* All the patients with endoscopy proven acute variceal haemorrhage (VH)
* Receiving Pre-EVL Terlipressin therapy
* EVL done within 24 hours of presentation
* Ready to give written informed consent

Exclusion Criteria:

* Patients with UGI bleed for more than 24 hours
* Not receiving pre-EVL Terlipressin therapy
* Pregnancy
* Past history of EVL
* Chronic kidney disease
* Patient's with EVL done beyond 24 hours of admission because of hemodynamic instability or encephalopathy
* Patients who are receiving blood thinners like anti-platelets, anti-coagulation agents within 4 weeks of presentation

Primary outcomes:
measure: Number of participants with Early-Rebleed
timeFrame: 5 days
measure: Number of participants with Rebleed
timeFrame: Within 2 Months
measure: Early-Mortality
timeFrame: 7 days
measure: Mortality
timeFrame: Within 2 Months
Secondary outcomes:
measure: Adverse drug events(ADE)
timeFrame: 5 days
measure: Hospital Stay
timeFrame: Maximum 2 Months
measure: Number of units of Blood transfusion during Hospital Stay
timeFrame: In hospital maximum upto 8 weeks
measure: Cost of therapy
timeFrame: In hospital maximum upto 8 weeks
measure: Complication
timeFrame: In hospital maximum upto 8 weeks
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Deba P Dhibar, MD
role: PRINCIPAL_INVESTIGATOR
References: