Comparison of the Effect of Warfarin and Direct Oral Anticoagulants

Comparison of the Effect of Warfarin and Direct Oral Anticoagulants on Upper Gastrointestinal System Bleeding

In this study, it was aimed to compare the frequency of new oral anticoagulants and warfarin usage, and to reveal the rates of recurrent upper gastrointestinal bleeding among patients who applied to our hospital with upper gastrointestinal bleeding

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Hemorrhage; Anticoagulants and Bleeding Disorders

Detailed Description

The data of all patients who applied to Samsun Training and Research Hospital Internal Medicine with a diagnosis of upper gastrointestinal bleeding and hospitalized by Internal Medicine and Gastroenterology clinics or who underwent outpatient endoscopy between 01.01.2021 and 31.12.2021 were included. The patients' data were analyzed from the patient files and hospital automation system retrospectively. Patients who had recurrent upper GI bleeding were detected by controlling them over the hospital software system and by reaching each patient again. The frequency of the new generation oral anticoagulants usage in patients with re-bleeding was determined, and data such as re-bleeding rate, length of hospital stay, need for transfusion, and mortality were analyzed in the groups who did not use this drug and those who used it. The patient demographics were also compared between the groups who were using the new generation oral anticoagulants, acetylsalicylic acid or warfarin.

• Study Type: Observational
• Enrollment (Actual): 346

Contacts and Locations

Study Locations

• Turkey
  • İlkadım
    • Samsun, İlkadım, Turkey
      • Samsun Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who were admitted to Samsun Training and Research Hospital with a diagnosis of upper gastrointestinal bleeding and hospitalized by Internal Medicine and Gastroenterology clinics or who underwent outpatient endoscopy were included in the study.

Description

Inclusion Criteria:

• Age >18 years old
• Upper gastrointestinal bleeding
• 12 months follow-up

Exclusion Criteria:

• Age <18 years old
• Lower gastrointestinal bleeding
• Esophageal variceal bleeding

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Patients with recurrent gastrointestinal bleeding; The data of all patients who applied to Samsun Training and Research Hospital for 12 months in 2022 and diagnosis of upper gastrointestinal bleeding and hospitalized by Internal Medicine and Gastroenterology clinics or who underwent outpatient endoscopy were included in the study.Patients who had recurrent upper GI bleeding were detected by controlling them over the hospital software system and by reaching each patient again. The frequency of use of new generation oral anticoagulants in patients with rebleeding was determined, and data such as rebleeding rate, length of hospital stay, need for transfusion, and mortality were analyzed in the groups who did not use this drug and those who used it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the incidence of recurrent bleeding	Increase or decrease in the incidence of recurrent bleeding	12 months

Collaborators and Investigators

• Sponsor: Samsun Education and Research Hospital
• Investigators: Principal Investigator: DÜRİYE SILA KARAGÖZ ÖZEN, MD, Samsun Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Oral Anticoagulant; Rebleeding; Gastrointestinal System; upper gastrointestinal system bleeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Gastrointestinal Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No