Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial

Launched by CLINICAL UROLOGY AND EPIDEMIOLOGY WORKING GROUP · Jul 23, 2024

Keywords

ClinConnect Summary

The ARTS trial is a research study looking at whether a medication called apixaban, which helps prevent blood clots, is effective for patients undergoing certain types of surgery, specifically abdominal or pelvic surgeries. The trial involves over 5,400 patients who are at a moderate risk for developing blood clots and bleeding. By comparing those who take apixaban to those who don’t take any blood-thinning medication, researchers hope to find out if using apixaban is beneficial or not for patients in this situation.

To be eligible for the trial, participants need to be adults aged 18 and older who are planning to have elective surgery and can provide informed consent. There are some important criteria that would exclude potential participants, such as having a recent major bleeding issue, certain medical conditions that increase bleeding risk, or being on certain medications. If you join the study, you will be randomly assigned to either take apixaban or to not take any anticoagulant. Throughout the study, your health will be monitored to ensure your safety and to gather important information on how effective the medication is in preventing blood clots.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed consent provided
• • Adult patients (≥18 years);
• • Undergoing elective abdominal or pelvic surgery at similar (and not high) risk of VTE and bleeding
• Exclusion Criteria:
• • Inability to provide informed consent
• • Patient with active bleeding/hemorrhage during the last 6 months if not expected to be treated by surgery planned
• • Lesion or condition if considered a significant risk factor for major bleeding
• • a. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
• • Anticoagulant treatment, antiplatelet treatment or omega-3 dietary supplement during previous 7 days preceding surgery and/or requiring within 30 days post-surgery
• • Patient who had during previous 6 months or are expected require within 30 days post-surgery chemotherapy/radiation or hormone therapy for cancer
• • Known thrombophilia
• • Known bleeding disorder
• • Substantial liver impairment (for instance INR 1.4 or more during last 60 days)
• • eGRF \<30 mL/min/1.73 m2
• • Platelet count \<100 × 109/L (that is, 100 000 mg/L)
• • Hb \<90 g/L (that is, \<9 g/dL)
• • ALT \>2 × upper limit of normal
• • Known allergy to apixaban
• • Taking strong inhibitors or inductors of both CYP 3A4 and P-glycoprotein, such as anti-seizure medications (e.g. phenytoin, fosphenytoin, carbamazepine), azole-antimycotics (e.g. ketoconazole, itraconazole), HIV-protease inhibitors (e.g. ritonavir, indinavir) and rifampicin
• • Concomitant procedures with high risk of VTE/bleeding
• • Previous VTE
• • Pregnant or breast-feeding female patients
• • Female participants who have had periods in the last 12 months and who are not using highly reliable contraception: (i) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); ii) progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); iii) intrauterine device (IUD); iv) intrauterine hormone-releasing system (IUS); v) bilateral tubal occlusion; vi) vasectomized partner; and vii) sexual abstinence from heterosexual intercourse during the entire period of risk associated with the study treatments
• • Previous randomization in this trial
• • Any reason why, in the opinion of the investigator(s), the patient should not participate