Upper Gastrointestinal BleedingRUGBENCT04825977
Risk Stratification of Patients Presenting With Upper Gastrointestinal Bleeding to the Emergency Department Using AIMS65 Score and Red Cell Distribution Width
An observational study of Upper Gastrointestinal Bleeding, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
Trial summary
The rationale of this study in UGIB patients is to assess whether the prediction of mortality and morbidity using AIMS65 score improves when used in combination with RDW in the emergency department setting. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- RISK STRATIFICATION USING AIMS65 SCORE AND RDW
- How many people
- 348 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2018to 31 Oct 2020
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: All adult (>18 years of age) patients presenting with UGIB to the ED of Jubilee Mission Medical College and Research Institute during the 18 months' time period were included in the study. The diagnosis of UGIB was based on patients' presentations, including coffee ground vomitus, hematemesis, melena, and blood in nasogastric aspirate. These patients were considered eligible for the study.
Who may be able to join
- All patients presenting to ED with UGIB
- Age more than 18 years of age
Who cannot join
- Patients not consenting to study
- Patients with known hematological disorders
- Patients in which endoscopy or blood transfusion is done outside
- Patients in which RDW value and laboratory parameters required for AIMS65 score are not available.
Trial locations and contacts
1 site in 1 country.
India1 site
Jubilee Mission Medical College and Research Institute
Thrissur, Kerala, 680027
About this study
The rationale of this study in UGIB patients is to assess whether the prediction of mortality and morbidity using AIMS65 score improves when used in combination with RDW in the emergency department setting.
Read the detailed description
UGIB is a ticking time-bomb and emergency physicians are challenged to accurately assess risk, and aggressively manage patients with gastrointestinal bleeding within the stipulated time in the confines of emergency department. If not managed properly, it is associated with high mortality.
Various clinical prediction scores help in risk stratifying such patients. Among the scores, AIMS65 score is the easy to use score and has good mortality predictive accuracy. RDW, once thought as marker of chronic blood loss has recently been identified as a good prognostic indicator as well as good predictor of mortality in conditions where there is acute blood loss.
Both AIMS65 score and RDW value have been used separately as a predictor of morbidity and mortality in patients with UGIB. But there are not much studies so far evaluating their combined role as marker of predicting mortality as well as high risk among UGIB patients. Hence there is a need for a study to know the predictive value of combination of AIMS6S score and RDW in patients presenting to ED with symptoms of UGIB not been much studies comparing the relationship between RDW and upper GI bleed.
The rationale of this study in UGIB patients is to assess whether the prediction of mortality and morbidity using AIMS65 score improves when used in combination with RDW in the emergency department setting.
- Conditions
- Upper Gastrointestinal Bleeding
- Being tested
- RISK STRATIFICATION USING AIMS65 SCORE AND RDW
- Keywords
- Emergency Department, Upper GI Bleed, Risk Stratification, Mortality, Red Cell Distribution Width, AIMS65 Score, Receiver Observer Characteristic Curve
- Medical subject headings
- Gastrointestinal Hemorrhage, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISK STRATIFICATION USING AIMS65 SCORE AND RDWOther
Risk Statification of patients presenting with upper gastrointestinal bleeding to the emergency department using AIMS65 score and Red cell Distribution Width.
What is being measured
The primary outcome is the main question the study is designed to answer.
predictive accuracy of addition of RDW to AIMS65 SCORE in determining the 30-day mortality of patients presenting to the ED with symptoms of UGIB
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Aug 2018
- Primary completion31 Mar 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal BleedingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jubilee Mission Medical College and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Vijay Chanchal A B, Jubilee Mission Medical College and Research Institute
- Investigators
- Siju V Abraham, MD, Study chair, Jubilee Mission Medical CollegeRajeev P C, MD, Study director, Jubilee Mission Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825977
- Sponsor's protocol ID
- 35/18/IEC/JMMC&RI
- Other IDs
- CTRI/2019/03/018127
- Acronym
- RUGBE
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification of Patients Presenting With Upper Gastrointestinal Bleeding to the Emergency Department Using AIMS65 Score and Red Cell Distribution Width
- ClinicalTrials.gov ID
- NCT04825977
- Acronym / sponsor ID
- RUGBE / 35/18/IEC/JMMC&RI
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- Emergency Department, Upper GI Bleed, Risk Stratification, Mortality, Red Cell Distribution Width, AIMS65 Score, Receiver Observer Characteristic Curve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Jubilee Mission Medical College and Research InstituteUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 1 Apr 2021 (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.
The rationale of this study in UGIB patients is to assess whether the prediction of mortality and morbidity using AIMS65 score improves when used in combination with RDW in the emergency department setting.
Detailed description
UGIB is a ticking time-bomb and emergency physicians are challenged to accurately assess risk, and aggressively manage patients with gastrointestinal bleeding within the stipulated time in the confines of emergency department. If not managed properly, it is associated with high mortality.
Various clinical prediction scores help in risk stratifying such patients. Among the scores, AIMS65 score is the easy to use score and has good mortality predictive accuracy. RDW, once thought as marker of chronic blood loss has recently been identified as a good prognostic indicator as well as good predictor of mortality in conditions where there is acute blood loss.
Both AIMS65 score and RDW value have been used separately as a predictor of morbidity and mortality in patients with UGIB. But there are not much studies so far evaluating their combined role as marker of predicting mortality as well as high risk among UGIB patients. Hence there is a need for a study to know the predictive value of combination of AIMS6S score and RDW in patients presenting to ED with symptoms of UGIB not been much studies comparing the relationship between RDW and upper GI bleed.
The rationale of this study in UGIB patients is to assess whether the prediction of mortality and morbidity using AIMS65 score improves when used in combination with RDW in the emergency department setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult (>18 years of age) patients presenting with UGIB to the ED of Jubilee Mission Medical College and Research Institute during the 18 months' time period were included in the study. The diagnosis of UGIB was based on patients' presentations, including coffee ground vomitus, hematemesis, melena, and blood in nasogastric aspirate. These patients were considered eligible for the study.
Key inclusion criteria (2 listed)
- All patients presenting to ED with UGIB
- Age more than 18 years of age
Key exclusion criteria (4 listed)
- Patients not consenting to study
- Patients with known hematological disorders
- Patients in which endoscopy or blood transfusion is done outside
- Patients in which RDW value and laboratory parameters required for AIMS65 score are not available.
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 |
|---|---|---|
| RISK STRATIFICATION USING AIMS65 SCORE AND RDWRisk Statification of patients presenting with upper gastrointestinal bleeding to the emergency department using AIMS65 score and Red cell Distribution Width. | Other | – |
Primary outcome
predictive accuracy of addition of RDW to AIMS65 SCORE in determining the 30-day mortality of patients presenting to the ED with symptoms of UGIB
Time frame: 30 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 1 Apr 2021.
Related trials for Upper Gastrointestinal Bleeding
Recruiting
OTSC vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding
Upper Gastrointestinal Bleeding
Recruiting
Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy
Acute Coronary Syndromes (ACS), Coronary Artery Disease (CAD)
Not yet recruitingPhase 3
Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke
Ischemic Stroke, Transient Ischemic Attack
Recruiting
Detection of Blood in the GI Lumen With HemoPill Acute
Upper GI Bleeding
Active, not recruitingObservational study
Impact of Diagnostic and Therapeutic Upper and Lower Gastrointestinal Endoscopic Management on Critically Ill Patients in Fayoum University Hospitals
GIT Bleeding
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.
Siju V Abraham, MD study chair
Jubilee Mission Medical College
Rajeev P C, MD study director
Jubilee Mission Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Gastrointestinal Bleeding, run by Jubilee Mission Medical College and Research Institute 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 2 inclusion and 4 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 1 Apr 2021. 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. 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?
predictive accuracy of addition of RDW to AIMS65 SCORE in determining the 30-day mortality of patients presenting to the ED with symptoms of UGIB (time frame: 30 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 1 Apr 2021.