RecruitingACTRN12617000654358

A prospective validation study of the Glasgow-Blatchford score

The utility of the Glasgow-Blatchford score in predicting clinical outcome and stratifying the need for therapeutic intervention in hospitalised patients with upper gastrointestinal bleeding: a prospective validating study.


Sponsor

Royal Adelaide Hospital

Enrollment

400 participants

Start Date

Apr 5, 2015

Study Type

Interventional

Conditions

Summary

The Glasgow-Blatchford score (GBS) has been shown to be superior to other scoring systems, such as the Rockall score, in predicting clinical outcomes and the need for endotherapy in hospitalised patients with upper gastrointestinal (UGI) bleeding. Specifically, our prospective observational study in 708 patients has recently found that a score of three or less identifies patients who do not require endoscopic intervention, blood transfusion, or surgery, and thus, could potentially be discharged early with conservative management and outpatient endoscopy. Despite the clinical implication of these findings, the use of the GBS in the management of UGI bleeding has not been adopted in practice at the Royal Adelaide Hospital. In order to further evaluate the use of the GBS to triage patients, we would like to prospectively validate the cut-off GBS of three or less in the outcome and management of patients with UGI haemorrhage (UGIH). More specifically, we would like to examine whether the GBS cut-off of three can determine the need for urgent endoscopy (within 24 hours), endotherapy, blood transfusion or surgery in these patients.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Upper gastrointestinal (GI) bleeding means bleeding from the stomach or upper small intestine — which can show up as vomiting blood or passing black, tarry stools. This study tests whether a scoring tool called the Glasgow-Blatchford Score (GBS) can reliably identify which patients can be safely discharged from hospital early, without needing urgent procedures. You may be eligible if: - You are 18 years old or older - You have been admitted to the Royal Adelaide Hospital with upper GI bleeding (vomiting blood or black stools) You may NOT be eligible if: - You cannot give informed consent and have no next of kin present - You have another urgent medical condition besides the bleeding - You have a known pre-existing cause of the bleed - You are pregnant - You live in a remote area or have no fixed address Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

A prospective validation study of the Glasgow-Blatchford Score The Gastroenterology and Emergency Department (ED) will be informed of the proposed research project, in the form of an oral presentat

A prospective validation study of the Glasgow-Blatchford Score The Gastroenterology and Emergency Department (ED) will be informed of the proposed research project, in the form of an oral presentation by the Principal Investigators. Both departments will identify patients presenting with upper gastrointestinal bleeding in ED. In order to facilitate their decision making, potential participants will be given a patient information sheet and consent form. Flyers have been placed around ED for awareness of the study in the department. Patients who meet the inclusion criteria, either in the Emergency Department or on the wards, will be invited to participate in the study via telephone. After being consented with the consent form, those patients with a Glasgow-Blatchford Score (GBS) of three or less will be discharged, and an outpatient endoscopy within 2 weeks will be performed. If patients have a GBS of greater than 3, they will be admitted to the Royal Adelaide Hospital and an endoscopy will be performed at the hospital within 24 hours. In both cases, if therapeutic intervention is required, this treatment will also be carried out. Patients will also receive one long term follow up phone call.


Locations(1)

SA, Australia

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ACTRN12617000654358


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