Anticoagulants and Bleeding DisordersNCT06269302
Comparison of the Effect of Warfarin and Direct Oral Anticoagulants
An observational study of Anticoagulants and Bleeding Disorders and Gastrointestinal Hemorrhage, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulants and Bleeding Disorders, Gastrointestinal Hemorrhage
- Type of treatment
- Pill or oral medicine
- How many people
- 346 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age >18 years old
- Upper gastrointestinal bleeding
- 12 months follow-up
Who cannot join
- Age <18 years old
- Lower gastrointestinal bleeding
- Esophageal variceal bleeding
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Education and Research Hospital
Samsun, İlkadım
About this study
Official title: 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
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.
- Keywords
- Gastrointestinal System, Oral Anticoagulant, Rebleeding, upper gastrointestinal system bleeding
- Medical subject headings
- Hemostatic Disorders, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in the incidence of recurrent bleeding
Increase or decrease in the incidence of recurrent bleeding
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulants and Bleeding DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duriye Sila Karagoz Ozen, Samsun Education and Research Hospital
- Investigators
- DÜRİYE SILA KARAGÖZ ÖZEN, MD, Principal investigator, Samsun Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269302
- Sponsor's protocol ID
- 2
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Warfarin and Direct Oral Anticoagulants on Upper Gastrointestinal System Bleeding
- ClinicalTrials.gov ID
- NCT06269302
- Acronym / sponsor ID
- 2
- Keywords
- Gastrointestinal System, Oral Anticoagulant, Rebleeding, upper gastrointestinal system bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Samsun Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age >18 years old
- Upper gastrointestinal bleeding
- 12 months follow-up
Key exclusion criteria (3 listed)
- Age <18 years old
- Lower gastrointestinal bleeding
- Esophageal variceal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the incidence of recurrent bleeding
Time frame: 12 months
Increase or decrease in the incidence of recurrent bleeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DÜRİYE SILA KARAGÖZ ÖZEN, MD principal investigator
Samsun Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulants and Bleeding Disorders and Gastrointestinal Hemorrhage, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the incidence of recurrent bleeding (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.