Acute Variceal HaemorrhagePhase 4TEVLNCT03584087
Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After EVL
A Phase 4 study testing Normal Saline and Terlipressin in people with Acute Variceal Haemorrhage, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Variceal Haemorrhage
- What is being tested?
- Normal Saline and Terlipressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteIndia
- Study dates
- 7 May 2018to 31 Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012
About this study
Official title: Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After Endoscopic Variceal Ligation: A Randomised Controlled Clinical Trial
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
- Being tested
- Normal Saline, Terlipressin
- Keywords
- Terlipressin, Variceal Haemorrhage, EVL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
TG 0 (0Hr)
TerlipressinDrug
Duration of Terlipressin after EVL
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 . Receives: Drug: Terlipressin |
| TG 5 (120Hr) | Active comparator | TG5 will receive Terlipressin (1mg, i.v. Bolus q 4 hourly) therapy for 120 hours after EVL . Receives: Drug: Terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Early-Rebleed
To evaluate the efficacy of Terlipressin therapy to prevent re-bleed after EVL in acute variceal Haemorrhage (VH)
Measured: 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)
Measured: Within 2 Months
Early-Mortality
To evaluate the efficacy of Terlipressin therapy to prevent mortality after EVL in acute VH
Measured: 7 days
Mortality
To evaluate the efficacy of Terlipressin therapy to prevent mortality after EVL in acute VH
Measured: Within 2 Months
Secondary outcomes (5)
Adverse drug events(ADE)
To evaluate ADE associated with Terlipressin therapy
Measured: 5 days
Hospital Stay
Duration of hospital Stay
Measured: Maximum 2 Months
Number of units of Blood transfusion during Hospital Stay
Number of units of Blood transfusion during Hospital Stay
Measured: In hospital maximum upto 8 weeks
Cost of therapy
Total cost of therapy during hospitalization
Measured: In hospital maximum upto 8 weeks
Complication
Hepatic encephalopathy, need for mechanical ventilation, sepsis, shock, hospital acquired Pneumonia
Measured: In hospital maximum upto 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start7 May 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Variceal HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deba Prasad Dhibar, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Deba P Dhibar, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584087
- Sponsor's protocol ID
- IEC/2018/000684
- Acronym
- TEVL
- Status last verified
- Dec 2019
- First submitted
- 26 May 2018
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After Endoscopic Variceal Ligation: A Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03584087
- Acronym / sponsor ID
- TEVL / IEC/2018/000684
- Conditions
- Acute Variceal Haemorrhage
- Keywords
- Terlipressin, Variceal Haemorrhage, EVL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TG 0 (0Hr) | Placebo comparator | Drug: Normal SalineTG0 will receive 10 ml of 0.9% normal saline (NS) IV bolus q 4 hourly in place of Terlipressin therapy after EVL. |
| TG 2 (48Hr) | Active comparator | Drug: TerlipressinTG2 will receive Terlipressin (1mg, i.v. Bolus q 4 hourly) therapy for 48 hours after EVL . |
| TG 5 (120Hr) | Active comparator | Drug: TerlipressinTG5 will receive Terlipressin (1mg, i.v. Bolus q 4 hourly) therapy for 120 hours after EVL . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Patients with UGI bleed for more than 24 hours
- Not receiving pre-EVL Terlipressin therapy
- Pregnancy
- Past history of EVL
- Chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal SalineTG 0 (0Hr) | Drug | TG 0 (0Hr) |
| TerlipressinDuration of Terlipressin after EVL | Drug | TG 2 (48Hr), TG 5 (120Hr) |
Primary outcome
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
5 secondary outcomes
Adverse drug events(ADE)
Time frame: 5 days
Hospital Stay
Time frame: Maximum 2 Months
Number of units of Blood transfusion during Hospital Stay
Time frame: In hospital maximum upto 8 weeks
Cost of therapy
Time frame: In hospital maximum upto 8 weeks
Complication
Time frame: In hospital maximum upto 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Acute Variceal Haemorrhage
Active, not recruiting
Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding
Acute Upper Gastrointestinal Bleeding, Acute Variceal Bleeding
Not yet recruiting
Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction
Liver Cirrhosis
Not yet recruiting
Keverprazan vs Pantoprazole for the Treatment of ANVUGIB
Non-variceal Upper Gastrointestinal Bleeding
RecruitingPhase 2
PPIs and In-Hospital Morbidity in Acute Variceal Bleeding With Chronic Liver Disease
Morbidity
Not yet recruitingObservational study
Acute Kidney Injury in Upper GI Bleeding Patients
Upper Gastrointestinal Bleeding, Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deba P Dhibar, MD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normal Saline and Terlipressin in people with Acute Variceal Haemorrhage, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Early-Rebleed (time frame: 5 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.