About this trial
The purpose of this study is to help find how safe current practices are when managing blood thinners in people with cancer who are having surgery or medical procedures. Investigators will also measure how often bleeding or clotting problems happen in this setting. The goal is to use this information to improve future care and reduce these risks for patients. This study will determine whether contemporary practices can be safely applied to cancer patients, and also evaluate the blood thinner level left over in patient's body at the time of surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Is undergoing a planned cancer-related inpatient or outpatient invasive procedure or cancer surgery (to diagnose, treat or palliate cancer; at investigator's discretion)
Interruption of anticoagulation therapy for the planned procedure is required.
Disqualifiers
Presence of any mechanical prosthetic heart valve
Known pregnancy or breastfeeding
Severe renal insufficiency (Creatinine Clearance (CrCl) < 30 mL/min or < 25 mL/min for Apixaban users)
Condition that might impair adherence to the study protocol (e.g., cognitive impairment, geographic inaccessibility) as determined by the treating physician
Trial design
Single group
Treatments tested in this trial
standardized perioperative anticoagulation management Guideline
Other interventionThe intervention is implementing a standardized perioperative anticoagulation management strategy in patients with active cancer (and this strategy is consistent with guideline-directed care for patients with active cancer).
Treatment groups
Trial outcomes
Primary outcomes
Major bleeding events
Major bleeding is defined according to International Society on Thrombosis and Haemostasis (ISTH) criteria as any of the following within 30 days post-surgery: Fatal bleeding; OR Symptomatic bleeding in a critical area or organ (e.g., intracranial, intraspinal, intraocular, retroperitoneal, pericardial, non-operated joint, or intramuscular with compartment syndrome); OR Extrasurgical site bleeding causing ≥20 g/L hemoglobin drop or requiring ≥2 units of blood transfusion within 24-48 hours; OR Surgical site bleeding requiring re-intervention or causing delayed mobilization, prolonged hospitalization, or deep wound infection; OR Unexpected/prolonged surgical site bleeding causing hemodynamic instability with ≥20 g/L hemoglobin drop or transfusion of ≥2 units within 24 hours.
Secondary outcomes
30-day combined risk of ATE (Arterial Thromboembolism ) /VTE (Venous Thromboembolism)
Includes arterial or venous thromboembolic events: stroke, TIA (Transient Ischemic Attack), systemic embolism, DVT (Deep Venous Thromboembolism), PE (Pulmonary Embolism), splanchnic vein thrombosis, or cerebral venous sinus thrombosis.
30-day risk of clinically relevant non-major bleeding (ISTH definition)
Bleeding that does not meet major criteria but requires medical intervention, unscheduled contact with a physician, interruption of anticoagulation, or causes discomfort impacting daily activities.
30-day risk of all-cause mortality
Death from any cause within 30 days post-surgery
Time to resumption of anticoagulation (therapeutic dosing)
Measured in hours from surgery to administration of therapeutic anticoagulant dose.
Sponsors and contacts
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