DRUG
Normal Saline
TG 0 (0Hr)
Status
Completed
Phase
Phase 4
Enrollment
74
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
TG 0 (0Hr)
DRUG
Duration of Terlipressin after EVL
Timeline
First posted
Jul 12, 2018
Study start
May 7, 2018
Primary completion
Jul 31, 2019
Study completion
Jul 31, 2019
Results posted
Not reported
Registry updated
Dec 16, 2019
Outcomes
Number of participants with Early-Rebleed
Time frame · 5 days
To evaluate the efficacy of Terlipressin therapy to prevent re-bleed after EVL in acute variceal Haemorrhage (VH)
Number of participants with Rebleed
Time frame · Within 2 Months
To evaluate the efficacy of Terlipressin therapy to prevent re-bleed after EVL in acute variceal Haemorrhage (VH)
Early-Mortality
Time frame · 7 days
To evaluate the efficacy of Terlipressin therapy to prevent mortality after EVL in acute VH
Mortality
Time frame · Within 2 Months
To evaluate the efficacy of Terlipressin therapy to prevent mortality after EVL in acute VH
Adverse drug events(ADE)
Time frame · 5 days
To evaluate ADE associated with Terlipressin therapy
Hospital Stay
Time frame · Maximum 2 Months
Duration of hospital Stay
Number of units of Blood transfusion during Hospital Stay
Time frame · In hospital maximum upto 8 weeks
Number of units of Blood transfusion during Hospital Stay
Cost of therapy
Time frame · In hospital maximum upto 8 weeks
Total cost of therapy during hospitalization
Complication
Time frame · In hospital maximum upto 8 weeks
Hepatic encephalopathy, need for mechanical ventilation, sepsis, shock, hospital acquired Pneumonia
Eligibility
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
Study locations
India. Showing up to 24 locations stored in the fast local snapshot.
Post Graduate Institute of Medical Education and Research
Chandigarh, India
Publications
No PMID-linked publications were present in this registry snapshot.
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