Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants

Launched by PEROSPHERE TECHNOLOGIES INC. · Aug 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how long it takes for blood to clot in patients who are taking certain blood-thinning medications called DOACs (direct oral anticoagulants). The researchers want to find out the normal clotting time ranges for these patients and see how these times relate to the levels of the medication in their blood. This information could help doctors better understand how these medications work and ensure patients are receiving the right treatment.

To participate in this trial, individuals need to be between 18 and 80 years old and must have been taking their prescribed anticoagulant medication regularly for at least a month. Participants will need to provide informed consent, which means they understand the study and agree to take part. They will also need to have a way for the researchers to collect blood samples. It’s important to note that certain health conditions or personal history, such as severe weight issues or recent bleeding problems, may prevent someone from participating. This study is not yet recruiting, so interested individuals will need to wait until it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * In general, study participants must:
• • 1. Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
• • 2. Be 18- to 80-years-of-age, inclusive, at time of consent.
• • 3. Have suitable venous access for at least a single venipuncture.
• • 4. Eligible patients on anticoagulants must have taken their prescribed anticoagulant regularly at least for one month prior to study participation for inclusion
• Exclusion Criteria:
• * Eligible patients on anticoagulants must not:
• • 1. Other than the condition for which a DOAC was prescribed , have a personal or family history of clotting disorder or hematologic abnormality, such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or any chronic condition requiring treatment with transfusions.
• • 2. Have a BMI\> 40 or weight \> 120kg.
• • 3. Suffer from renal or hepatic insufficiency.
• • 4. Suffer from any pathology that would contra-indicate in general DOAC medication.
• • 5. Have a history of unexplained syncope.
• • 6. Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).
• • 7. Consume more than 5 cigarettes per day.
• • 8. If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
• • 9. If female is pregnant, breastfeeding, or planning to become pregnant during study