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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-3hstqm
Enrollment
Unknown
Registered
2020-02-11
Start date
2016-07-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive system diseases

Interventions

A case-control study (1 case: 3 controls), paired by sex and age (+ - 5 years) is being conducted. The cases and controls are being collected in four hospitals in the Hospital das Clínicas hospital co
the Ribeirão Preto Emergency Unit, an emergency hospital with 300 beds
the Ribeirão Preto State Hospital, a 60-bed secondary level hospital
and Hospital Estadual de Américo Brasiliense, a 110-bed secondary-level hospital. This hospital complex serves the population of the health region of northwest São Paulo (Regional Health Departments -
Other
E05.318.372.500.500

Sponsors

Universidade Estadual Paulista (UNESP)
Lead Sponsor
Universidade Estadual Paulista (UNESP)
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Variable dependent: diagnosis of upper gastrointestinal bleeding through upper gastrointestinal endoscopy or surgical intervention; ;Variable independent: presence of the genetic determinants PTGS1, eNOS, VKOCR1, ABCB1 and CYP2C9;;Variables intervenient: use of ASA, 100 mg (maior que six months) in the indication of antiplatelet therapy; family history and history of gastric morbidities, chronic morbidities; H. pylori infection; pharmacotherapy in use; and smoking habits; alcohol and caffeine consumption.

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactMarcela;Maria Forgerini;Herdeiro

Universidade Estadual Paulista (UNESP);Universidade de Aveiro

marcelaforgerini@gmail.com;teresaherdeiro@ua.pt+55(35)991956789;+351917739799

Outcome results

None listed

Source: REBEC (via WHO ICTRP)