Re-bleeding in NVUGIBNIS-PUBNCT01292915
Survey of Non-Variceal Upper Gastro Intestinal Bleeding in Vietnamese Patients
An observational study of Re-bleeding in NVUGIB, run by AstraZeneca at 3 sites in Vietnam.
Trial summary
The main aim of the study is to describes the outcomes of patients with Upper Gastrointestinal Bleed (UGIB) in a real-life setting. Additionally analyse assessed predictors of outcome, including the impact of hemostatic endoscopic and pharmacologic therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Re-bleeding in NVUGIB
- How many people
- 1,044 participants
- Where
- 3 sitesVietnam
- Study dates
- Oct 2011to Jan 2013
- Phase
- Observational
- 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
Study population: NVUGIB patients in 13 hospitals in Hanoi, HCMC, Danang
Who may be able to join
- Adult patients (>=18yrs) admitted to the hospital, or inpatients admitted for another reason, presenting with overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia...
- Evidence that an upper GI endoscopy was performed
Who cannot join
- GI bleeding not from NVUGIB
Trial locations and contacts
3 sites in 1 country.
Vietnam3 sites
Research Site
Da Nang
Research Site
Hanoi
Research Site
HoChiMinh City
About this study
The main aim of the study is to describes the outcomes of patients with Upper Gastrointestinal Bleed (UGIB) in a real-life setting. Additionally analyse assessed predictors of outcome, including the impact of hemostatic endoscopic and pharmacologic therapies.
Read the detailed description
MSD
- Conditions
- Re-bleeding in NVUGIB
- Keywords
- Re-bleeding, NVUGIB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding (within 7 days from the Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB) episode)
Measured: 7 days
Secondary outcomes (3)
Surgery due to re-bleeding
Measured: 7 days
Mortality due to bleeding
Measured: 7 days
Rebleeding in high risk peptic ulcer patients
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Re-bleeding in NVUGIBStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,044 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dao Van Long, MD,PhD, Principal investigator, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292915
- Sponsor's protocol ID
- NIS-GVN-DUM-2010/1
- Acronym
- NIS-PUB
- Status last verified
- May 2014
- First submitted
- 9 Feb 2011
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Non-Variceal Upper Gastro Intestinal Bleeding in Vietnamese Patients
- ClinicalTrials.gov ID
- NCT01292915
- Acronym / sponsor ID
- NIS-PUB / NIS-GVN-DUM-2010/1
- Conditions
- Re-bleeding in NVUGIB
- Keywords
- Re-bleeding, NVUGIB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,044 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Feb 2011 (estimated)
- 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.
The main aim of the study is to describes the outcomes of patients with Upper Gastrointestinal Bleed (UGIB) in a real-life setting. Additionally analyse assessed predictors of outcome, including the impact of hemostatic endoscopic and pharmacologic therapies.
Detailed description
MSD
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NVUGIB patients in 13 hospitals in Hanoi, HCMC, Danang
Key inclusion criteria (2 listed)
- Adult patients (>=18yrs) admitted to the hospital, or inpatients admitted for another reason, presenting with overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia...
- Evidence that an upper GI endoscopy was performed
Key exclusion criteria (1 listed)
- GI bleeding not from NVUGIB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rebleeding (within 7 days from the Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB) episode)
Time frame: 7 days
3 secondary outcomes
Surgery due to re-bleeding
Time frame: 7 days
Mortality due to bleeding
Time frame: 7 days
Rebleeding in high risk peptic ulcer patients
Time frame: 7 days
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 May 2014.
- CSR\_Synopsis\_NIS-GVN-DUM-2010\_1Link provided by the sponsor.
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.
Dao Van Long, MD,PhD principal investigator
Hanoi Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Re-bleeding in NVUGIB, run by AstraZeneca at 3 sites in Vietnam.
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 2 inclusion and 1 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 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Vietnam. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Rebleeding (within 7 days from the Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB) episode) (time frame: 7 days). 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 May 2014.