Patients With Acute Upper Gastrointestinal BleedingNCT05773339
Prognostic Value of AIMS65 Score to Predict Outcome in Patients With Acute Upper Gastrointestinal Bleeding
An observational study of Patients With Acute Upper Gastrointestinal Bleeding, run by Sohag University at 1 site in Egypt.
Trial summary
Prognostic Value of AIMS65 Score to predict outcome in patients with acute upper gastrointestinal bleeding Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Acute Upper Gastrointestinal Bleeding
- What is being tested?
- AIMS65 score
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to Sep 2023
- 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: Patients above 18 years of age. * Patients with acute UGIB presenting within 24 hours of hemorrhage onset. * Endoscopic evaluation done after hospital admission.
Who may be able to join
- o Patients above 18 years of age.
- Patients with acute UGIB presenting within 24 hours of hemorrhage onset.
- Endoscopic evaluation done after hospital admission.
Who cannot join
- o Patients denying for consent.
- Patients with late presentation (>24 hours) after UGIB onset.
Trial locations and contacts
1 site in 1 country.
Ali T Ali, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag, Sohag
Magdy M Amin, professor
About this study
Prognostic Value of AIMS65 Score to predict outcome in patients with acute upper gastrointestinal bleeding
Read the detailed description
Gastrointestinal (GI) bleeding is one of the most important disease presentations in the emergency department. The course of the disease ranges from a self-limiting process to a life-threatening condition that requires emergency intervention. Evaluation of severity and the need for endoscopic hemostasis are matters of immediate decision. several prognostic scoring systems have been used to predict outcomes of upper GI bleeding ,such as the Rockall score, Glasgow-Blatchford score (GBS), and the AIMS65 score, among which AIMS65 is relatively easy to remember and simple to calculate by using parameters routinely available in the ED and importantly does not require endoscopic variables for calculation..
The AIMS65 score consists of five factors:
(i)albumin (1 point for value less than 3.0 g/dL (30 g/L)). (ii)INR (1 point for value greater than 1.5) . (iii)altered mental status (1 point given if Glasgow coma score was less than 14 or if disorientation, lethargy, stupor, or coma was seen) (iv)systolic blood pressure (1 point for value less than 90 mmHg). (v)age (1 point for value greater than 65 years). AIMS65 score >1: high risk patients. AIMS65 score >2: consider ICU management and an urgent endoscopy following adequate volume resuscitation, while AIMS65 score of 0 can be considered for outpatient management.
AIMS65 score is a simple non-endoscopic risk score that can be applied in patients of acute upper gastrointestinal bleeding to risk stratify and to predict in-patient mortality, the need for blood transfusion, endoscopic therapy or ICU admission.
In a comparative study of AIMS65 score and GBS ,they found that the AIMS65 score was superior in predicting inpatient mortality from UGIB, while the GBS was superior for predicting the need for blood transfusion. Both scores were similar in predicting the composite clinical endpoint .
- Being tested
- AIMS65 score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIMS65 scoreOther
The AIMS65 score consists of five factors:
(i)albumin (1 point for value less than 3.0 g/dL (30 g/L)). (ii)INR (1 point for value greater than 1.5) . (iii)altered mental status (1 point given if Glasgow coma score was less than 14 or if disorientation, lethargy, stupor, or coma was seen) (iv)systolic blood pressure (1 point for value less than 90 mmHg). (v)age (1 point for value greater than 65 years).
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the prognostic value of AIMS65 score in patients with upper gastrointestinal tract bleeding admitted to Sohag University Hospital.
blood transfusion endoscopic therapy ICU admission Need of surgery, incidence of rebleeding duration of hospital and ICU stay.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Mar 2023
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patients With Acute Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nessma Mahmoud Abbas, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773339
- Sponsor's protocol ID
- Soh-Med-23-02-07
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Saltzman JR, Tabak YP, Hyett BH, Sun X, Travis AC, Johannes RS. A simple risk score accurately predicts in-hospital mortality, length of stay, and cost in acute upper GI bleeding. Gastrointest Endosc. 2011 Dec;74(6):1215-24. doi: 10.1016/j.gie.2011.06.024. Epub 2011 Sep 10.
PubMed 21907980Bryant RV, Kuo P, Williamson K, Yam C, Schoeman MN, Holloway RH, Nguyen NQ. Performance of the Glasgow-Blatchford score in predicting clinical outcomes and intervention in hospitalized patients with upper GI bleeding. Gastrointest Endosc. 2013 Oct;78(4):576-83. doi: 10.1016/j.gie.2013.05.003. Epub 2013 Jun 18.
PubMed 23790755Thandassery RB, Sharma M, John AK, Al-Ejji KM, Wani H, Sultan K, Al-Mohannadi M, Yakoob R, Derbala M, Al-Dweik N, Butt MT, Al-Kaabi SR. Clinical Application of AIMS65 Scores to Predict Outcomes in Patients with Upper Gastrointestinal Hemorrhage. Clin Endosc. 2015 Sep;48(5):380-4. doi: 10.5946/ce.2015.48.5.380. Epub 2015 Sep 30.
PubMed 26473120Stanley AJ, Laine L, Dalton HR, Ngu JH, Schultz M, Abazi R, Zakko L, Thornton S, Wilkinson K, Khor CJ, Murray IA, Laursen SB; International Gastrointestinal Bleeding Consortium. Comparison of risk scoring systems for patients presenting with upper gastrointestinal bleeding: international multicentre prospective study. BMJ. 2017 Jan 4;356:i6432. doi: 10.1136/bmj.i6432.
PubMed 28053181
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of AIMS65 Score to Predict Outcome in Patients With Acute Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT05773339
- Acronym / sponsor ID
- Soh-Med-23-02-07
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 17 Mar 2023 (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.
Prognostic Value of AIMS65 Score to predict outcome in patients with acute upper gastrointestinal bleeding
Detailed description
Gastrointestinal (GI) bleeding is one of the most important disease presentations in the emergency department. The course of the disease ranges from a self-limiting process to a life-threatening condition that requires emergency intervention. Evaluation of severity and the need for endoscopic hemostasis are matters of immediate decision. several prognostic scoring systems have been used to predict outcomes of upper GI bleeding ,such as the Rockall score, Glasgow-Blatchford score (GBS), and the AIMS65 score, among which AIMS65 is relatively easy to remember and simple to calculate by using parameters routinely available in the ED and importantly does not require endoscopic variables for calculation..
The AIMS65 score consists of five factors:
(i)albumin (1 point for value less than 3.0 g/dL (30 g/L)). (ii)INR (1 point for value greater than 1.5) . (iii)altered mental status (1 point given if Glasgow coma score was less than 14 or if disorientation, lethargy, stupor, or coma was seen) (iv)systolic blood pressure (1 point for value less than 90 mmHg). (v)age (1 point for value greater than 65 years). AIMS65 score >1: high risk patients. AIMS65 score >2: consider ICU management and an urgent endoscopy following adequate volume resuscitation, while AIMS65 score of 0 can be considered for outpatient management.
AIMS65 score is a simple non-endoscopic risk score that can be applied in patients of acute upper gastrointestinal bleeding to risk stratify and to predict in-patient mortality, the need for blood transfusion, endoscopic therapy or ICU admission.
In a comparative study of AIMS65 score and GBS ,they found that the AIMS65 score was superior in predicting inpatient mortality from UGIB, while the GBS was superior for predicting the need for blood transfusion. Both scores were similar in predicting the composite clinical endpoint .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients above 18 years of age. * Patients with acute UGIB presenting within 24 hours of hemorrhage onset. * Endoscopic evaluation done after hospital admission.
Key inclusion criteria (3 listed)
- o Patients above 18 years of age.
Key exclusion criteria (2 listed)
- o Patients denying for consent.
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 |
|---|---|---|
| AIMS65 scoreThe AIMS65 score consists of five factors: (i)albumin (1 point for value less than 3.0 g/dL (30 g/L)). (ii)INR (1 point for value greater than 1.5) . (iii)altered mental status (1 point given if Glasgow coma score was less than 14 or if disorientation, lethargy, stupor, or coma was seen) (iv)systolic blood pressure (1 point for value less than 90 mmHg). (v)age (1 point for value greater than 65 years). | Other | – |
Primary outcome
to evaluate the prognostic value of AIMS65 score in patients with upper gastrointestinal tract bleeding admitted to Sohag University Hospital.
Time frame: 6 months
blood transfusion endoscopic therapy ICU admission Need of surgery, incidence of rebleeding duration of hospital and ICU stay.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 21907980Saltzman JR, Tabak YP, Hyett BH, Sun X, Travis AC, Johannes RS. A simple risk score accurately predicts in-hospital mortality, length of stay, and cost in acute upper GI bleeding. Gastrointest Endosc. 2011 Dec;74(6):1215-24. doi: 10.1016/j.gie.2011.06.024. Epub 2011 Sep 10.
- Background: PubMed 23790755Bryant RV, Kuo P, Williamson K, Yam C, Schoeman MN, Holloway RH, Nguyen NQ. Performance of the Glasgow-Blatchford score in predicting clinical outcomes and intervention in hospitalized patients with upper GI bleeding. Gastrointest Endosc. 2013 Oct;78(4):576-83. doi: 10.1016/j.gie.2013.05.003. Epub 2013 Jun 18.
- Background: PubMed 26473120Thandassery RB, Sharma M, John AK, Al-Ejji KM, Wani H, Sultan K, Al-Mohannadi M, Yakoob R, Derbala M, Al-Dweik N, Butt MT, Al-Kaabi SR. Clinical Application of AIMS65 Scores to Predict Outcomes in Patients with Upper Gastrointestinal Hemorrhage. Clin Endosc. 2015 Sep;48(5):380-4. doi: 10.5946/ce.2015.48.5.380. Epub 2015 Sep 30.
- Background: PubMed 28053181Stanley AJ, Laine L, Dalton HR, Ngu JH, Schultz M, Abazi R, Zakko L, Thornton S, Wilkinson K, Khor CJ, Murray IA, Laursen SB; International Gastrointestinal Bleeding Consortium. Comparison of risk scoring systems for patients presenting with upper gastrointestinal bleeding: international multicentre prospective study. BMJ. 2017 Jan 4;356:i6432. doi: 10.1136/bmj.i6432.
- Individual participant dataSharing planned: Yes
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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.
Ali T Ali, professor contact
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 Patients With Acute Upper Gastrointestinal Bleeding, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Mar 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nessma M abbass, resident (01009692981, nesmamahmoud@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the prognostic value of AIMS65 score in patients with upper gastrointestinal tract bleeding admitted to Sohag University Hospital. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05773339, which also lists 4 linked publications.
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 31 Mar 2023.