Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After EVL

NCT03584087 | Completed Phase 4 DMC

• 1 other identifier: IEC/2018/000684
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Variceal Haemorrhage

Keywords

Terlipressin, Variceal Haemorrhage, EVL

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Early-Mortality

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

  7 days

• Mortality

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

  Within 2 Months

Secondary Outcomes (5)

• Adverse drug events(ADE)

  5 days

• Hospital Stay

  Maximum 2 Months

• Number of units of Blood transfusion during Hospital Stay

  In hospital maximum upto 8 weeks

• Cost of therapy

  In hospital maximum upto 8 weeks

• Complication

  In hospital maximum upto 8 weeks

Study Arms (3)

TG 0 (0Hr)

PLACEBO COMPARATOR

TG0 will receive 10 ml of 0.9% normal saline (NS) IV bolus q 4 hourly in place of Terlipressin therapy after EVL.

Drug: Normal Saline

TG 2 (48Hr)

ACTIVE COMPARATOR

TG2 will receive Terlipressin (1mg, i.v. Bolus q 4 hourly) therapy for 48 hours after EVL .

Drug: Terlipressin

TG 5 (120Hr)

ACTIVE COMPARATOR

TG5 will receive Terlipressin (1mg, i.v. Bolus q 4 hourly) therapy for 120 hours after EVL .

Drug: Terlipressin

Interventions

Normal Saline DRUG

TG 0 (0Hr)

TG 0 (0Hr)

Terlipressin DRUG

Duration of Terlipressin after EVL

TG 2 (48Hr); TG 5 (120Hr)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

MeSH Terms

Interventions

Saline Solution; Terlipressin

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Deba P Dhibar, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 26, 2018
• First Posted: July 12, 2018
• Study Start: May 7, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: December 16, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)