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

Active Cancer Patients Having Cancer Related Invasive Procedures or Surgery and Needing Perioperative Management of Anticoagulation Therapy (ACE-HIGH): A Prospective Management Cohort Study

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 Overview

• Status: Not yet recruiting
• Conditions: Cancer; Thrombosis; Bleeding; Atrial Fibrillation (AF); Thrombosis, Deep Vein; Venous Thromboembolic Event
• Intervention / Treatment: Other: standardized perioperative anticoagulation management Guideline

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph Shaw, MD, MSc, FRCPC; Phone Number: 74630 613-737-8899; Email: josshaw@ohri.ca
• Study Contact Backup: Name: Marc Carrier, MD; Phone Number: 6137378899; Email: mcarrier@toh.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: study intervention; 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).

Other: standardized perioperative anticoagulation management Guideline; The 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of study follow ups at 4 weeks"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	30 days
30-day risk of all-cause mortality	Death from any cause within 30 days post-surgery	30 days
Time to resumption of anticoagulation (therapeutic dosing)	Measured in hours from surgery to administration of therapeutic anticoagulant dose.	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.	Perioperative/Periprocedural
Pre-operative thrombin generation assay (TGA) parameters	Lag Time (in minutes)	Perioperative/Periprocedural
Pre-operative thrombin generation assay (TGA) parameters	Time to Peak (in minutes)	Perioperative/Periprocedural
Pre-operative thrombin generation assay (TGA) parameters	Peak thrombin generation (peak; in nM)	Perioperative/Periprocedural
Pre-operative thrombin generation assay (TGA) parameters	Endogenous thrombin potential (ETP; in nM/min)	Perioperative/Periprocedural
Pre-operative thrombin generation assay (TGA) parameters	Mean velocity rate index (mVRI; in nM/min).	Perioperative/Periprocedural

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Joseph Shaw, MD, MSc, FRCPC, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Atrial fibrillation; bleeding; thrombosis; VTE; Anticoagulant Interruption
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Embolism and Thrombosis; Pathological Conditions, Signs and Symptoms; Neoplasms; Thrombosis; Venous Thrombosis; Atrial Fibrillation; Hemorrhage
• Other Study ID Numbers: ACE-HIGH 20250647-01T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No