Post Graduate Institute of Medical Education and Research
Chandigarh, 160012, India
NCT Number: NCT03584087
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Chandigarh, 160012, India
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TG 0 (0Hr)
Duration of Terlipressin after EVL
Time frame: 5 days
To evaluate the efficacy of Terlipressin therapy to prevent re-bleed after EVL in acute variceal Haemorrhage (VH)
Time frame: Within 2 Months
To evaluate the efficacy of Terlipressin therapy to prevent re-bleed after EVL in acute variceal Haemorrhage (VH)
Time frame: 7 days
To evaluate the efficacy of Terlipressin therapy to prevent mortality after EVL in acute VH
Time frame: Within 2 Months
To evaluate the efficacy of Terlipressin therapy to prevent mortality after EVL in acute VH
Time frame: 5 days
To evaluate ADE associated with Terlipressin therapy
Time frame: Maximum 2 Months
Duration of hospital Stay
Time frame: In hospital maximum upto 8 weeks
Number of units of Blood transfusion during Hospital Stay
Time frame: In hospital maximum upto 8 weeks
Total cost of therapy during hospitalization
Time frame: In hospital maximum upto 8 weeks
Hepatic encephalopathy, need for mechanical ventilation, sepsis, shock, hospital acquired Pneumonia
Post Graduate Institute of Medical Education and Research, Chandigarh
Other
Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After Endoscopic Variceal Ligation: A Randomised Controlled Clinical Trial
Acronym: TEVL
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