Current partner codePEPTIDESDE
NCT03584087·Phase 4·INTERVENTIONAL

Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After EVL

Status

Completed

Phase

Phase 4

Enrollment

74

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Normal Saline

TG 0 (0Hr)

DRUG

Terlipressin

Duration of Terlipressin after EVL

Timeline

From registration to results.

  1. First posted

    Jul 12, 2018

  2. Study start

    May 7, 2018

  3. Primary completion

    Jul 31, 2019

  4. Study completion

    Jul 31, 2019

  5. Results posted

    Not reported

  6. Registry updated

    Dec 16, 2019

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

1 registered sites.

India. Showing up to 24 locations stored in the fast local snapshot.

Post Graduate Institute of Medical Education and Research

Chandigarh, India

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Terlipressin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.