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Completed

NCT Number: NCT03584087

Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After EVL

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Post Graduate Institute of Medical Education and Research

Chandigarh, 160012, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal saline

Drug

TG 0 (0Hr)

Terlipressin

Drug

Duration of Terlipressin after EVL

Primary outcomes

  1. 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)

  2. 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)

  3. Early-Mortality

    Time frame: 7 days

    To evaluate the efficacy of Terlipressin therapy to prevent mortality after EVL in acute VH

  4. Mortality

    Time frame: Within 2 Months

    To evaluate the efficacy of Terlipressin therapy to prevent mortality after EVL in acute VH

Secondary outcomes

  1. Adverse drug events(ADE)

    Time frame: 5 days

    To evaluate ADE associated with Terlipressin therapy

  2. Hospital Stay

    Time frame: Maximum 2 Months

    Duration of hospital Stay

  3. 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

  4. Cost of therapy

    Time frame: In hospital maximum upto 8 weeks

    Total cost of therapy during hospitalization

  5. Complication

    Time frame: In hospital maximum upto 8 weeks

    Hepatic encephalopathy, need for mechanical ventilation, sepsis, shock, hospital acquired Pneumonia

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Acronym: TEVL

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2018
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.