Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Nov 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called edoxaban to prevent blood clots that can occur in cancer patients who have catheters (thin tubes placed in the body to deliver medications or fluids). The study is specifically looking at patients who are at higher risk for these types of blood clots. To participate, individuals must be at least 18 years old, have a diagnosed cancer, and meet certain health criteria, such as being able to live for at least six more months and not having serious bleeding issues.

Participants in this trial will receive edoxaban and will be monitored for any side effects and for how well the medication helps prevent blood clots. It’s important to note that this trial is not yet recruiting participants, so people will need to wait until it officially starts. If you or a loved one are interested in participating, it's a good idea to discuss it with a healthcare provider to see if it’s a suitable option.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age≥18.
• • 2. Cancer patients with a catheter-related thrombus risk prediction model score ≥ 19.6.
• • 3. ECOG score≤2.
• • 4. Expected survival period over 6 months.
• • 5. Malignant tumor was diagnosed by pathology and central venous catheterization was successfully completed.
• • 6. Signing of informed consent voluntarily.
• Exclusion Criteria:
• • 1. Unknown location of the primary tumor.
• • 2. Allergy to the active ingredient of edoxaban tablets or other excipients.
• • 3. There is clinically significant active bleeding.
• • 4. Platelet \<50×109/L.
• • 5. Liver disease with coagulopathy or clinically relevant bleeding risk.
• • 6. A lesion or condition with a significant risk of major bleeding, such as current or recent gastrointestinal ulcer, recent brain or spinal injury, recent brain, spinal, or ophthalmic surgery, recent intracranial hemorrhage, esophageal varices, arteriovenous malformations, vascular aneurysms, or major intravertebral or intracerebral vascular malformations.
• • 7. Concomitant therapy with any other anticoagulant, such as Unfractionated heparin (UFH), Low molecular heparin (Low molecular weight heparin, LMWH) (enoxaparin, dalteparin, etc.), heparin derivative (fondaparinux, etc.), oral anticoagulant (warfarin, dabigatran, rivaroxaban, apixaban, etc.), except in the special case of administration of UFH to maintain central venous catheter patency.
• • 8. Surgical treatment is planned for the duration of the study.
• 9. Uncontrolled co-morbidities include, but are not limited to:
• • Serious, uncontrolled infection. Symptomatic heart failure (New York Heart Association class II-IV) or symptomatic or poorly controlled arrhythmias Uncontrolled hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) despite standard treatment.
• • Any arterial thromboembolic event within 6 months before enrollment. Tumor invasion of large vessels. History of deep vein thrombosis, pulmonary embolism, or other major thromboembolism within 3 months before enrollment.
• • 10. History of gastrointestinal perforation within 6 months before enrollment.
• • 11. Pregnant or breastfeeding women.
• • 12. Oral contraceptives.
• • 13. Conditions considered unsuitable for inclusion in this study.