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Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After EVL (TEVL)

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ClinicalTrials.gov Identifier: NCT03584087
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Deba Prasad Dhibar, Postgraduate Institute of Medical Education and Research

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.

Condition or disease Intervention/treatment Phase
Acute Variceal Haemorrhage Drug: Normal Saline Drug: Terlipressin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After Endoscopic Variceal Ligation: A Randomised Controlled Clinical Trial
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Placebo Comparator: TG 0 (0Hr)
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 0 (0Hr)

Active Comparator: TG 2 (48Hr)
TG2 will receive Terlipressin (1mg, i.v. Bolus q 4 hourly) therapy for 48 hours after EVL .
Drug: Terlipressin
Duration of Terlipressin after EVL

Active Comparator: TG 5 (120Hr)
TG5 will receive Terlipressin (1mg, i.v. Bolus q 4 hourly) therapy for 120 hours after EVL .
Drug: Terlipressin
Duration of Terlipressin after EVL




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584087


Contacts
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Contact: Deba P Dhibar, MD +919530881462 drdeba_prasad@yahoo.co.in

Locations
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India
Post Graduate Institute of Medical Education and Research Recruiting
Chandigarh, India, 160012
Contact: Deba P Dhibar, MD    +919530881462    drdeba_prasad@yahoo.co.in   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Principal Investigator: Deba P Dhibar, MD Post Graduate Institute of Medical Education and Research

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Responsible Party: Deba Prasad Dhibar, Assistant Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03584087     History of Changes
Other Study ID Numbers: IEC/2018/000684
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Deba Prasad Dhibar, Postgraduate Institute of Medical Education and Research:
Terlipressin, Variceal Haemorrhage, EVL

Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Terlipressin
Antihypertensive Agents
Vasoconstrictor Agents