Safety of Perioperative Anticoagulation Management in People With Active Cancer Undergoing Cancer-Related Surgery or Procedures (ACE-HIGH Study)

N/ANot Yet RecruitingNCT07372716

Ottawa Hospital Research Institute700 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

700

Conditions

Thrombosis Cancer Thrombosis, Deep Vein Atrial Fibrillation (AF)Venous Thromboembolic Event

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Prescribed a Direct Oral Anticoagulant (DOAC), warfarin (International Normalized Ratio (INR) target 2.0-3.0) or Low Molecular Weight Heparin (LMWH) (75-100% weight-based therapeutic dosing) for stroke prevention in Atrial Fibrillation (AF) or the treatment of Venous Thromboembolism (VTE). Eligible DOAC regimens include full-dose (therapeutic) DOAC regimens appropriate for age and renal function. Eligible DOAC regimens include: i. Apixaban 10 mg po BID (VTE) ii. Apixaban 5 mg po BID (AF or VTE) iii. Apixaban 2.5 mg po BID (AF) iv. Rivaroxaban 15 mg po BID (VTE) v. Rivaroxaban 20 mg po OD (AF or VTE) vi. Rivaroxaban 15 mg po OD (AF only) vii. Edoxaban 60 mg po OD (AF or VTE) viii. Edoxaban 30 mg po OD (AF or VTE) ix. Dabigatran 150 mg po BID (AF or VTE) x. Dabigatran 110 mg po BID (AF) * Has active cancer, defined as: i. cancer diagnosed within 6 months ii. recurrent, regionally advanced, or metastatic cancer iii. cancer for which treatment had been administered within 6 months before enrolment iv. hematologic cancer that is not in remission v. Patients who are felt to likely have active cancer based on clinical/imaging characteristics but are awaiting tissue confirmation and are scheduled for a biopsy procedure are eligible for trial inclusion * 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. Exclusion Criteria: * 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 * Allergy to heparin or a history of (Heparin Induced Thrombocytopenia (HIT) * More than one surgery/procedure planned during the study period * Previous study participation * Inability to provide informed consent

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.

Time frame: From enrollment to the end of study follow ups at 4 weeks"

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.

Time frame: 30 days

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.

Time frame: 30 days

30-day risk of all-cause mortality

Death from any cause within 30 days post-surgery

Time frame: 30 days

Time to resumption of anticoagulation (therapeutic dosing)

Measured in hours from surgery to administration of therapeutic anticoagulant dose.

Time frame: hours from surgery to administration of therapeutic anticoagulant dose.

Pre-operative residual anticoagulant levels

Measured at Visit #3 prior to surgery using drug-specific assays.