Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After EVL

Acute Variceal Haemorrhage Clinical Trial

— TEVL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584087
• Other study ID #: IEC/2018/000684
• Status: Completed
• Phase: Phase 4
• Start date: May 7, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: December 2019
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Acute Variceal Haemorrhage
• Hemorrhage

Intervention

Drug:
• Normal Saline
TG 0 (0Hr)
• Terlipressin
Duration of Terlipressin after EVL

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Early-Rebleed	To evaluate the efficacy of Terlipressin therapy to prevent re-bleed after EVL in acute variceal Haemorrhage (VH)	5 days
Primary	Number of participants with Rebleed	To evaluate the efficacy of Terlipressin therapy to prevent re-bleed after EVL in acute variceal Haemorrhage (VH)	Within 2 Months
Primary	Early-Mortality	To evaluate the efficacy of Terlipressin therapy to prevent mortality after EVL in acute VH	7 days
Primary	Mortality	To evaluate the efficacy of Terlipressin therapy to prevent mortality after EVL in acute VH	Within 2 Months
Secondary	Adverse drug events(ADE)	To evaluate ADE associated with Terlipressin therapy	5 days
Secondary	Hospital Stay	Duration of hospital Stay	Maximum 2 Months
Secondary	Number of units of Blood transfusion during Hospital Stay	Number of units of Blood transfusion during Hospital Stay	In hospital maximum upto 8 weeks
Secondary	Cost of therapy	Total cost of therapy during hospitalization	In hospital maximum upto 8 weeks
Secondary	Complication	Hepatic encephalopathy, need for mechanical ventilation, sepsis, shock, hospital acquired Pneumonia	In hospital maximum upto 8 weeks