Safe Discharge in Lower Gastrointestinal Bleeding

Lower GI Bleeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06409988
• Other study ID #: EO ALTA SEGURA
• Status: Completed
• Start date: June 1, 2014
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2024
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: December 30, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Lower GI Bleeding

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (15)

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. — View Citation

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 Gas — View Citation

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. — View Citation

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. — View Citation

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: 10.1080/00365521.2018.15 — View Citation

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. — View Citation

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 perforati — View Citation

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 Pharm — View Citation

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 B — View Citation

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 — View Citation

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 Ne — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic characterisctics of our cohort	Description of the main characteristics of the patients admitted due to lower gastrointestinal bleeding	After 1 month of follow-up from the hospital discharge
Primary	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
Primary	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	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.	After 1 month of follow-up from the hospital discharge
Secondary	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.	After 1 month of follow-up from the hospital discharge