Genetic determinants of gastrointestinal hemorrhage associated with the use of acetylsalicylic acid as an antiplatelet agent: a case-control study

Not Applicable

Recruiting

• Conditions: Digestive system diseases; Stomach Ulcer; Duodenal Ulcer; Aspirin; Drug-Related Side Effects and Adverse Reactions; C06.405.469.275.800.849; C06.405.469.275.800.348; B03.440.500.550; D02.455.426.559.389.657.410.595.176; C25.100

• Registration Number: RBR-3hstqm
• Lead Sponsor: niversidade Estadual Paulista (UNESP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-11
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Cases: cases will be considered all patients over 18 years of age who have complicated peptic disease, characterized by upper gastrointestinal bleeding (UGIB) or perforated ulcers, and meet the following criteria: entered the study hospitals with a complaint of UGIB, characterized by the presence hematemesis, dark vomiting or coffee grounds, melena and / or hematochezia and have undergone upper digestive endoscopy (UDE), in which one of the following findings was identified: gastric or duodenal ulcers, erosions, acute lesions of the gastric mucosa or duodenal, gastritis or erosive duodenitis (with or without active or recent bleeding); patients who did not show symptoms of UGIB, but who had undergone UDE for different reasons and during the same signs of recent bleeding (active bleeding, clot adhered, visible vessel) are observed; patients who entered with symptoms of acute perforating abdomen, confirmed by imaging exams (X-ray or computed tomography) and who underwent a surgical procedure, in which it was confirmed to be a peptic ulcer perforation (gastric or duodenal).Control: to prevent control selection from being associated with exposure to acetylsalicylic acid (ASA), controls will be recruited from the preoperative unit among patients who will undergo mild and scheduled surgeries of a non-painful clinical process and not associated with the use of ASA (cataracts, inguinal hernias) / umbilicals or prostate adenomas).

Exclusion Criteria

Cases: as primary exclusion criteria for cases, those who: entered the study hospitals complaining of UGIB by other endoscopic diagnoses, such as esophageal varices, gastric neoplasia, hiatal hernia and Mallory-Weiss syndrome will be excluded; patients with in-hospital UGIB; patients with UGIB without diagnosis by upper digestive endoscopy (UDE). Secondary exclusion criteria include: cases whose endoscopy has not been performed within 48 hours after admission to the hospital, or, in the case of outpatients, those whose endoscopy has been scheduled for more than 7 days; patients who were not interviewed until 15 days after admission to the hospital; (iii) critically ill patients and (iv) death. Cases and controls: Under 18 years old; history of neoplasia and coagulopathies; HIV positive patients; narcotics; carriers of a nasogastric or percutaneous tube; patients who went to the hospital for any reason 15 days before the current admission (cases) or the interview (controls); and non-residents of the region for at least three months will be excluded.

Study & Design

• Study Type: Observational
• Study Design: Not specified