Lower GI BleedingNCT06409988
Safe Discharge in Lower Gastrointestinal Bleeding
An observational study of Lower GI Bleeding, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
The increasing incidence in lower gastrointestinal bleeding (LGIB) leads to a rise in hospital admission. Many LGBI are self-limiting thus the several scores to identify low risk patients suited to outpatient care have been described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower GI Bleeding
- What is being tested?
- Safe discharge
- How many people
- 398 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2014to 30 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients will be selected after discharge from hospitalization in the gastroenterology department during the stablished time period.
Who may be able to join
- All > 18 year old patients, male and women, admitted to our hospital between June 2014 and June 2019 because of LGIB (lower gastrointestinal bleeding).
Who cannot join
- Patients in whom LGIB occurred while already admitted for an other cause.
- Patients with LGIB transferred from another hospital due to comorbidities or severity of the gastrointestinal bleeding episode.
- Patients with post-polypectomy LGIB (endoscopic polypectomy <14 days before admission).
- Patients with gastrointestinal bleeding of unknown origin after a complete study.
- Patients who had undergone digestive tract surgery in the previous month.
- Patients with an ostomy.
- Patients with known colorectal cancer who had not undergone surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Validation of the SHA2PE Score and Its Comparison to the Oakland Score for the Prediction of Safe Discharge in Patients With Lower Gastrointestinal Bleeding
The increasing incidence in lower gastrointestinal bleeding (LGIB) leads to a rise in hospital admission. Many LGBI are self-limiting thus the several scores to identify low risk patients suited to outpatient care have been described. We aim to compare two of this scores (Oakland score and SHA2PE score) in terms of performace to predict "safe discharge" from the emergency department.
Read the detailed description
The growing incidence of lower gastrointestinal bleeding (LGIB) is leading to a rise in hospital admissions even though most LGIB episodes are self-limiting. The Oakland and SHA2PE scores were designed to identify patients best suited to outpatient care. Our aim is to validate the SHA2PE score and compare both of these scores in terms of predictiveness of safe discharge.
We conducted a retrospective observational study of LGIB patients admitted to our hospital between June 2014-June 2019. During this period, data from all LGIB episodes admitted from the ED were collected in an electronic anonymized database created specifically for this study. If any of the principal variables or critical information was missing, the patient was excluded from the study.
- Conditions
- Lower GI Bleeding
- Being tested
- Safe discharge
- Keywords
- Discharge, lower gastrointestinal bleeding, Oakland score, SHA2PE score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe dischargeOther
There was no specific intervention, we only aimed to see if those admitted patients could have been safely dicharged from the emergency department.
| Study group | Role | What they receive |
|---|---|---|
| Patients with lower gastrointestinal bleeding | Any >18 years old patient admitted to our hospital due to a lower gastrointestinal bleeding episode. Receives: Other: Safe discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe Discharge
Patients with lower gastrointestinal bleeding and absence of all the following: rebleeding, re-consulting for LGIB within 28 days after discharge, in-hospital mortality, requirement of red blood cell transfusion or endoscopic, radiological, or surgical haemostatic treatment.
Measured: After 1 month of follow-up from the hospital discharge
Validation of SHA2PE score in our cohort
We aim to validate this score in a southern Europe cohort and compare it to the Oakland score
Measured: After 1 month of follow-up from the hospital discharge
Secondary outcomes (2)
Performance of Oakland score in safe discharge
We calculated the sensibility, specificity, positive and negative predictive values of the Oakland score in our patients cohort.
Measured: After 1 month of follow-up from the hospital discharge
Performance of SHA2PE score in safe discharge
We calculated the sensibility, specificity, positive and negative predictive values of the SHA2PE score in our patients cohort.
Measured: After 1 month of follow-up from the hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Jun 2014
- Primary completion1 Jun 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Lower GI 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
- Retrospective
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Gonzalez, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409988
- Sponsor's protocol ID
- EO ALTA SEGURA
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Oakland K, Chadwick G, East JE, Guy R, Humphries A, Jairath V, McPherson S, Metzner M, Morris AJ, Murphy MF, Tham T, Uberoi R, Veitch AM, Wheeler J, Regan C, Hoare J. Diagnosis and management of acute lower gastrointestinal bleeding: guidelines from the British Society of Gastroenterology. Gut. 2019 May;68(5):776-789. doi: 10.1136/gutjnl-2018-317807. Epub 2019 Feb 12.
PubMed 30792244Aoki T, Hirata Y, Yamada A, Koike K. Initial management for acute lower gastrointestinal bleeding. World J Gastroenterol. 2019 Jan 7;25(1):69-84. doi: 10.3748/wjg.v25.i1.69.
PubMed 30643359Lanas A, Garcia-Rodriguez LA, Polo-Tomas M, Ponce M, Alonso-Abreu I, Perez-Aisa MA, Perez-Gisbert J, Bujanda L, Castro M, Munoz M, Rodrigo L, Calvet X, Del-Pino D, Garcia S. Time trends and impact of upper and lower gastrointestinal bleeding and perforation in clinical practice. Am J Gastroenterol. 2009 Jul;104(7):1633-41. doi: 10.1038/ajg.2009.164. Epub 2009 May 5.
PubMed 19574968Lanas A, Garcia-Rodriguez LA, Polo-Tomas M, Ponce M, Quintero E, Perez-Aisa MA, Gisbert JP, Bujanda L, Castro M, Munoz M, Del-Pino MD, Garcia S, Calvet X. The changing face of hospitalisation due to gastrointestinal bleeding and perforation. Aliment Pharmacol Ther. 2011 Mar;33(5):585-91. doi: 10.1111/j.1365-2036.2010.04563.x. Epub 2011 Jan 5.
PubMed 21205256Oakland K. Changing epidemiology and etiology of upper and lower gastrointestinal bleeding. Best Pract Res Clin Gastroenterol. 2019 Oct-Dec;42-43:101610. doi: 10.1016/j.bpg.2019.04.003. Epub 2019 Apr 17.
PubMed 31785737Strate LL. Lower GI bleeding: epidemiology and diagnosis. Gastroenterol Clin North Am. 2005 Dec;34(4):643-64. doi: 10.1016/j.gtc.2005.08.007.
PubMed 16303575Chait MM. Lower gastrointestinal bleeding in the elderly. World J Gastrointest Endosc. 2010 May 16;2(5):147-54. doi: 10.4253/wjge.v2.i5.147.
PubMed 21160742Comay D, Marshall JK. Resource utilization for acute lower gastrointestinal hemorrhage: the Ontario GI bleed study. Can J Gastroenterol. 2002 Oct;16(10):677-82. doi: 10.1155/2002/156592.
PubMed 12420025Xavier SA, Machado FJ, Magalhaes JT, Cotter JB. Acute lower gastrointestinal bleeding: are STRATE and BLEED scores valid in clinical practice? Colorectal Dis. 2019 Mar;21(3):357-364. doi: 10.1111/codi.14529. Epub 2019 Jan 10.
PubMed 30537416Strate LL, Orav EJ, Syngal S. Early predictors of severity in acute lower intestinal tract bleeding. Arch Intern Med. 2003 Apr 14;163(7):838-43. doi: 10.1001/archinte.163.7.838.
PubMed 12695275Aoki T, Nagata N, Shimbo T, Niikura R, Sakurai T, Moriyasu S, Okubo H, Sekine K, Watanabe K, Yokoi C, Yanase M, Akiyama J, Mizokami M, Uemura N. Development and Validation of a Risk Scoring System for Severe Acute Lower Gastrointestinal Bleeding. Clin Gastroenterol Hepatol. 2016 Nov;14(11):1562-1570.e2. doi: 10.1016/j.cgh.2016.05.042. Epub 2016 Jun 14.
PubMed 27311620Kollef MH, O'Brien JD, Zuckerman GR, Shannon W. BLEED: a classification tool to predict outcomes in patients with acute upper and lower gastrointestinal hemorrhage. Crit Care Med. 1997 Jul;25(7):1125-32. doi: 10.1097/00003246-199707000-00011.
PubMed 9233736Oakland K, Jairath V, Uberoi R, Guy R, Ayaru L, Mortensen N, Murphy MF, Collins GS. Derivation and validation of a novel risk score for safe discharge after acute lower gastrointestinal bleeding: a modelling study. Lancet Gastroenterol Hepatol. 2017 Sep;2(9):635-643. doi: 10.1016/S2468-1253(17)30150-4. Epub 2017 Jun 23.
PubMed 28651935Oakland K, Kothiwale S, Forehand T, Jackson E, Bucknall C, Sey MSL, Singh S, Jairath V, Perlin J. External Validation of the Oakland Score to Assess Safe Hospital Discharge Among Adult Patients With Acute Lower Gastrointestinal Bleeding in the US. JAMA Netw Open. 2020 Jul 1;3(7):e209630. doi: 10.1001/jamanetworkopen.2020.9630.
PubMed 32633766Hreinsson JP, Sigurdardottir R, Lund SH, Bjornsson ES. The SHA2PE score: a new score for lower gastrointestinal bleeding that predicts low-risk of hospital-based intervention. Scand J Gastroenterol. 2018 Dec;53(12):1484-1489. doi: 10.1080/00365521.2018.1532019. Epub 2018 Nov 20.
PubMed 30457020
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of the SHA2PE Score and Its Comparison to the Oakland Score for the Prediction of Safe Discharge in Patients With Lower Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT06409988
- Acronym / sponsor ID
- EO ALTA SEGURA
- Conditions
- Lower GI Bleeding
- Keywords
- Discharge, lower gastrointestinal bleeding, Oakland score, SHA2PE score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 10 May 2024 (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 increasing incidence in lower gastrointestinal bleeding (LGIB) leads to a rise in hospital admission. Many LGBI are self-limiting thus the several scores to identify low risk patients suited to outpatient care have been described. We aim to compare two of this scores (Oakland score and SHA2PE score) in terms of performace to predict "safe discharge" from the emergency department.
Detailed description
The growing incidence of lower gastrointestinal bleeding (LGIB) is leading to a rise in hospital admissions even though most LGIB episodes are self-limiting. The Oakland and SHA2PE scores were designed to identify patients best suited to outpatient care. Our aim is to validate the SHA2PE score and compare both of these scores in terms of predictiveness of safe discharge.
We conducted a retrospective observational study of LGIB patients admitted to our hospital between June 2014-June 2019. During this period, data from all LGIB episodes admitted from the ED were collected in an electronic anonymized database created specifically for this study. If any of the principal variables or critical information was missing, the patient was excluded from the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with lower gastrointestinal bleeding | – | Other: Safe dischargeAny >18 years old patient admitted to our hospital due to a lower gastrointestinal bleeding episode. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be selected after discharge from hospitalization in the gastroenterology department during the stablished time period.
Key inclusion criteria (1 listed)
- All > 18 year old patients, male and women, admitted to our hospital between June 2014 and June 2019 because of LGIB (lower gastrointestinal bleeding).
Key exclusion criteria (7 listed)
- Patients in whom LGIB occurred while already admitted for an other cause.
- Patients with LGIB transferred from another hospital due to comorbidities or severity of the gastrointestinal bleeding episode.
- Patients with post-polypectomy LGIB (endoscopic polypectomy <14 days before admission).
- Patients with gastrointestinal bleeding of unknown origin after a complete study.
- Patients who had undergone digestive tract surgery in the previous month.
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 |
|---|---|---|
| Safe dischargeThere was no specific intervention, we only aimed to see if those admitted patients could have been safely dicharged from the emergency department. | Other | Patients with lower gastrointestinal bleeding |
Primary outcome
Safe Discharge
Time frame: After 1 month of follow-up from the hospital discharge
Patients with lower gastrointestinal bleeding and absence of all the following: rebleeding, re-consulting for LGIB within 28 days after discharge, in-hospital mortality, requirement of red blood cell transfusion or endoscopic, radiological, or surgical haemostatic treatment.
Validation of SHA2PE score in our cohort
Time frame: After 1 month of follow-up from the hospital discharge
We aim to validate this score in a southern Europe cohort and compare it to the Oakland score
2 secondary outcomes
Performance of Oakland score in safe discharge
Time frame: After 1 month of follow-up from the hospital discharge
Performance of SHA2PE score in safe discharge
Time frame: After 1 month of follow-up from the hospital discharge
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 10 May 2024.
- Results publication: PubMed 30792244Oakland K, Chadwick G, East JE, Guy R, Humphries A, Jairath V, McPherson S, Metzner M, Morris AJ, Murphy MF, Tham T, Uberoi R, Veitch AM, Wheeler J, Regan C, Hoare J. Diagnosis and management of acute lower gastrointestinal bleeding: guidelines from the British Society of Gastroenterology. Gut. 2019 May;68(5):776-789. doi: 10.1136/gutjnl-2018-317807. Epub 2019 Feb 12.
- Results publication: PubMed 30643359Aoki T, Hirata Y, Yamada A, Koike K. Initial management for acute lower gastrointestinal bleeding. World J Gastroenterol. 2019 Jan 7;25(1):69-84. doi: 10.3748/wjg.v25.i1.69.
- Results publication: PubMed 19574968Lanas A, Garcia-Rodriguez LA, Polo-Tomas M, Ponce M, Alonso-Abreu I, Perez-Aisa MA, Perez-Gisbert J, Bujanda L, Castro M, Munoz M, Rodrigo L, Calvet X, Del-Pino D, Garcia S. Time trends and impact of upper and lower gastrointestinal bleeding and perforation in clinical practice. Am J Gastroenterol. 2009 Jul;104(7):1633-41. doi: 10.1038/ajg.2009.164. Epub 2009 May 5.
- Results publication: PubMed 21205256Lanas A, Garcia-Rodriguez LA, Polo-Tomas M, Ponce M, Quintero E, Perez-Aisa MA, Gisbert JP, Bujanda L, Castro M, Munoz M, Del-Pino MD, Garcia S, Calvet X. The changing face of hospitalisation due to gastrointestinal bleeding and perforation. Aliment Pharmacol Ther. 2011 Mar;33(5):585-91. doi: 10.1111/j.1365-2036.2010.04563.x. Epub 2011 Jan 5.
- Results publication: PubMed 31785737Oakland K. Changing epidemiology and etiology of upper and lower gastrointestinal bleeding. Best Pract Res Clin Gastroenterol. 2019 Oct-Dec;42-43:101610. doi: 10.1016/j.bpg.2019.04.003. Epub 2019 Apr 17.
- Results publication: PubMed 16303575Strate LL. Lower GI bleeding: epidemiology and diagnosis. Gastroenterol Clin North Am. 2005 Dec;34(4):643-64. doi: 10.1016/j.gtc.2005.08.007.
- Results publication: PubMed 21160742Chait MM. Lower gastrointestinal bleeding in the elderly. World J Gastrointest Endosc. 2010 May 16;2(5):147-54. doi: 10.4253/wjge.v2.i5.147.
- Results publication: PubMed 12420025Comay D, Marshall JK. Resource utilization for acute lower gastrointestinal hemorrhage: the Ontario GI bleed study. Can J Gastroenterol. 2002 Oct;16(10):677-82. doi: 10.1155/2002/156592.
- Results publication: PubMed 30537416Xavier SA, Machado FJ, Magalhaes JT, Cotter JB. Acute lower gastrointestinal bleeding: are STRATE and BLEED scores valid in clinical practice? Colorectal Dis. 2019 Mar;21(3):357-364. doi: 10.1111/codi.14529. Epub 2019 Jan 10.
- Results publication: PubMed 12695275Strate LL, Orav EJ, Syngal S. Early predictors of severity in acute lower intestinal tract bleeding. Arch Intern Med. 2003 Apr 14;163(7):838-43. doi: 10.1001/archinte.163.7.838.
- Results publication: PubMed 27311620Aoki T, Nagata N, Shimbo T, Niikura R, Sakurai T, Moriyasu S, Okubo H, Sekine K, Watanabe K, Yokoi C, Yanase M, Akiyama J, Mizokami M, Uemura N. Development and Validation of a Risk Scoring System for Severe Acute Lower Gastrointestinal Bleeding. Clin Gastroenterol Hepatol. 2016 Nov;14(11):1562-1570.e2. doi: 10.1016/j.cgh.2016.05.042. Epub 2016 Jun 14.
- Results publication: PubMed 9233736Kollef MH, O'Brien JD, Zuckerman GR, Shannon W. BLEED: a classification tool to predict outcomes in patients with acute upper and lower gastrointestinal hemorrhage. Crit Care Med. 1997 Jul;25(7):1125-32. doi: 10.1097/00003246-199707000-00011.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
Related trials for Lower GI Bleeding
Not yet recruiting
Endoscopic Application of Hemostatic Drug Powder in Lower Gastrointestinal Bleeding: A Pilot Study
Bleeding After GI Endoscopy
Not yet recruitingObservational study
Gastrointestinal Bleeding is Blood Loss in the Digestive Tract, Classified as Upper or Lower. Ischemic Heart Disease is Due to Blocked Heart Arteries. Antiplatelet Drugs Help Prevent Heart Attacks But Increase GI Bleeding Risk, Especially When Used Together as Dual Therapy.
Gastro Intestinal Bleeding, Ischaemic Heart Diseases
Not yet recruitingPhase 4
Trial of Low-intensity Anticoagulation to Reduce GI or Other Bleeding Complications With Equivalent Therapeutic Efficacy in HeartMate 3 LVAD Patients
Advanced Heart Failure, Left Ventricular Assist Devices
Not yet recruitingObservational study
Endoscopic Findings in Patients Presented With Lower GIT Bleeding in Assiut University Hospitals, a Single-centre Study
Lower Gastrointestinal Bleeding
Enrolling by invitation
Urgent Panendoscopy in Patients Presenting With Hematochezia
Lower Gastrointestinal Bleeding, Small Bowel 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lower GI Bleeding, run by Germans Trias i Pujol Hospital at 1 site in Spain.
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 1 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 10 May 2024. 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 Spain. 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?
Safe Discharge (time frame: After 1 month of follow-up from the hospital discharge). The study lists 2 primary outcomes in all. 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 NCT06409988, which also lists 15 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 10 May 2024.