Safe Discharge in Lower Gastrointestinal Bleeding

NCT06409988 | Completed

• 1 other identifier: EO ALTA SEGURA
• Study Type: observational
• Target: 398
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lower GI Bleeding

Keywords

Discharge; lower gastrointestinal bleeding; Oakland score; SHA2PE score

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  After 1 month of follow-up from the hospital discharge

Secondary Outcomes (2)

• Performance of Oakland score in safe discharge

  After 1 month of follow-up from the hospital discharge

• Performance of SHA2PE score in safe discharge

  After 1 month of follow-up from the hospital discharge

Other Outcomes (1)

• Demographic characterisctics of our cohort

  After 1 month of follow-up from the hospital discharge

Study Arms (1)

Patients with lower gastrointestinal bleeding

Any \>18 years old patient admitted to our hospital due to a lower gastrointestinal bleeding episode.

Other: Safe discharge

Interventions

Safe discharge OTHER

There was no specific intervention, we only aimed to see if those admitted patients could have been safely dicharged from the emergency department.

Patients with lower gastrointestinal bleeding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients will be selected after discharge from hospitalization in the gastroenterology department during the stablished time period.

You may qualify if:

• All \> 18 year old patients, male and women, admitted to our hospital between June 2014 and June 2019 because of LGIB (lower gastrointestinal bleeding).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

Location

Related Publications (15)

• 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.

  PMID: 30792244 RESULT

• Aoki 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.

  PMID: 30643359 RESULT

• Lanas 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.

  PMID: 19574968 RESULT

• Lanas 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.

  PMID: 21205256 RESULT

• Oakland 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.

  PMID: 31785737 RESULT

• Strate 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.

  PMID: 16303575 RESULT

• Chait 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.

  PMID: 21160742 RESULT

• Comay 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.

  PMID: 12420025 RESULT

• Xavier 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.

  PMID: 30537416 RESULT

• Strate 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.

  PMID: 12695275 RESULT

• Aoki 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.

  PMID: 27311620 RESULT

• Kollef 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.

  PMID: 9233736 RESULT

• Oakland 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.

  PMID: 28651935 RESULT

• Oakland 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.

  PMID: 32633766 RESULT

• Hreinsson 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.

  PMID: 30457020 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laura González González

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: June 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: December 30, 2020
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From July 2020 to January 2025
• Access Criteria: The information will be shared under mail request, under a Word document if the IP of the study considers it necessary

Locations

ES (1)