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ORBIT Versus HAS-BLED Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants.

ORBIT Versus HAS-BLED Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05975320
Enrollment
100
Registered
2023-08-03
Start date
2023-08-31
Completion date
2024-02-29
Last updated
2023-08-03

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

Conditions

Patients With Atrial Fibrillation Receiving Oral Anticoagulants

Brief summary

Atrial fibrillation (AF) is type of arrhythmia characterized by an irregular and often rapid heartbeats, it has strong associations with other cardiovascular diseases, such as heart failure, coronary artery disease (CAD), valvular heart disease, diabetes mellitus, thyrotoxicosis and hypertension. Atrial fibrillation is the most frequent cardiac arrhythmia. It has been estimated that 6-12 million people worldwide will suffer this condition in the US by 2050 and 17.9 million people in Europe by 2060. Atrial fibrillation is a major risk factor for ischemic stroke and provokes important economic burden along with significant morbidity and mortality . (AF) is arrhythmia with the potential to cause thromboembolism. Studies suggest that AF increases the risk of stroke five-folds. Stroke prevention is central to the management of patients with atrial fibrillation (AF), and effective stroke prevention requires oral anticoagulation (OAC). Either a vitamin K antagonist (VKA; e.g. warfarin) or a non-VKA oral anticoagulant (NOAC) . It's essential reach the balance between prevention of thromboembolic as well as bleeding events during the anticoagulant use.

Interventions

DRUGWarfarin

Patients receiving oral anticoagulants will be followed up for 6 months to detect occurrence of any major bleeding events include (spontaneous epistaxis , spontaneous bleeding per gums , hematemesis , bleeding per rectum , intracranial hemorrhage and internal hemorrhage ). Then, incidence of bleeding events using both (HAS-BLED) & (ORBIT) SCORES will be calculated and compared for all cases .

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* All patients with atrial fibrillation : 1. Aged 18 years old or older . 2. Underwent cardiac valve replacement 3. Who have valvular heart disease receiving anticoagulants . 4. Who have non valvular AF in whom CHA2DS 2VASc score 2 or more. 5. Receiving either vitamin K antagonist e.g warfarin or NOAC .

Exclusion criteria

1. Patients age less than 18 years old 2. Patients receiving anticoagulants without atrial fibrillations 3. Pregnant patients with AF 4. Patients with AF on Non oral anticoagulants

Design outcomes

Primary

MeasureTime frameDescription
incidence of bleeding events using both (HAS-BLED) & (ORBIT) SCORES6 monthsPatients receiving oral anticoagulants will be followed up for 6 months to detect occurrence of any major bleeding events include (spontaneous epistaxis , spontaneous bleeding per gums , hematemesis , bleeding per rectum , intracranial hemorrhage and internal hemorrhage ). Then, incidence of bleeding events using both (HAS-BLED) & (ORBIT) SCORES will be calculated and compared for all cases .

Contacts

Primary ContactYasmeen M Al-anwer, Resident
yassminmohamed@med.sohag.edu.eg01152631299
Backup Contactlotfy H Abo Dahab, Professor
01003459739

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026