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Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After EVL

NCT ID: NCT03584087

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-07

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Variceal Haemorrhage

Keywords

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Terlipressin, Variceal Haemorrhage, EVL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

TG 0 (0Hr)

TG 2 (48Hr)

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

Group Type ACTIVE_COMPARATOR

Terlipressin

Intervention Type DRUG

Duration of Terlipressin after EVL

TG 5 (120Hr)

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

Group Type ACTIVE_COMPARATOR

Terlipressin

Intervention Type DRUG

Duration of Terlipressin after EVL

Interventions

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Normal Saline

TG 0 (0Hr)

Intervention Type DRUG

Terlipressin

Duration of Terlipressin after EVL

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Deba Prasad Dhibar

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deba P Dhibar, MD

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

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Post Graduate Institute of Medical Education and Research

Chandigarh, , India

Site Status

Countries

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India

Other Identifiers

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IEC/2018/000684

Identifier Type: -

Identifier Source: org_study_id