NCT06269302

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

February 12, 2024

Last Update Submit

February 12, 2024

Conditions

Keywords

Gastrointestinal SystemOral AnticoagulantRebleedingupper gastrointestinal system bleeding

Outcome Measures

Primary Outcomes (1)

  • Change in the incidence of recurrent bleeding

    Increase or decrease in the incidence of recurrent bleeding

    12 months

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun Education and Research Hospital

Samsun, İlkadım, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemostatic DisordersGastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesGastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • DÜRİYE SILA KARAGÖZ ÖZEN, MD

    Samsun Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Internal Medicine Specialist

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 21, 2024

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations