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

Ottawa Hospital Research Institute

Status: Begins enrollment this month

Conditions: Venous Thromboembolic Event; Thrombosis; Thrombosis, Deep Vein; Atrial Fibrillation (AF); Cancer; Bleeding

Treatments: Other: standardized perioperative anticoagulation management Guideline

Study type: Interventional

Funder types: Other

Identifiers

NCT07372716

ACE-HIGH 20250647-01T

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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700 participants in 1 patient group

study intervention

Other group

Description:

The intervention consists of applying perioperative anticoagulation management strategies based on contemporary guidelines for non-cancer patients to a cancer population undergoing invasive procedures or surgery. This study is a pragmatic, guideline-informed interventional study. It does not involve testing a novel drug, biologic, or device, and therefore does not align with clinical trial phases (Phase I-IV).

Treatment:

Other: standardized perioperative anticoagulation management Guideline