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CompletedNCT06269302Updated Feb 21, 2024

Comparison of the Effect of Warfarin and Direct Oral Anticoagulants

An observational study in Anticoagulants and Bleeding Disorders and Gastrointestinal Hemorrhage, sponsored by Samsun Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-21.

Sponsored by Samsun Education and Research Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
346
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Anticoagulants and Bleeding Disorders
  • Gastrointestinal Hemorrhage

Keywords

  • Gastrointestinal System
  • Oral Anticoagulant
  • Rebleeding
  • upper gastrointestinal system bleeding
03

In context

Hemostatic Disorders

361 studies on the registry are indexed under Hemostatic Disorders; 65 are open to participants now.

This study's enrollment of 346 is above the median of 120 across 174 observational studies indexed under Hemostatic Disorders.

Browse Hemostatic Disorders studies →

Lead sponsor

Samsun Education and Research Hospital is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years old
  • Lower gastrointestinal bleeding
  • Esophageal variceal bleeding
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
346 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Change in the incidence of recurrent bleeding

    Increase or decrease in the incidence of recurrent bleeding

    Time frame: 12 months

07

Study locations

1 site
  • Samsun Education and Research Hospital
    Samsun, İlkadım, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2022 to primary completion in Dec 2022, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2024
First posted
Feb 21, 2024
StartActual
Jan 1, 2022
Primary completionActual
Dec 31, 2022
CompletionActual
Dec 31, 2022
Last update
Feb 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06269302
Lead sponsor
Samsun Education and Research Hospital
Responsible party
Duriye Sila Karagoz Ozen (MD, Internal Medicine Specialist, Samsun Education and Research Hospital) — Principal investigator
First posted
Feb 21, 2024
Start date
Jan 1, 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Feb 21, 2024

Study contacts

DÜRİYE SILA KARAGÖZ ÖZEN, MD
principal investigator · Samsun Education and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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