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

NCT07372716 | Not Yet Recruiting DMC

• 1 other identifier: ACE-HIGH 20250647-01T
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

thrombosis; Atrial fibrillation; Cancer; Anticoagulant Interruption; VTE; bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 30-day combined risk of ATE (Arterial Thromboembolism ) /VTE (Venous Thromboembolism)

  30 days

• 30-day risk of clinically relevant non-major bleeding (ISTH definition)

  30 days

• 30-day risk of all-cause mortality

  30 days

• Time to resumption of anticoagulation (therapeutic dosing)

  hours from surgery to administration of therapeutic anticoagulant dose.

• Pre-operative residual anticoagulant levels

  Perioperative/Periprocedural

Study Arms (1)

study intervention

OTHER

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

Interventions

standardized perioperative anticoagulation management Guideline OTHER

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).

study intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

MeSH Terms

Conditions

Thrombosis; Neoplasms; Venous Thrombosis; Atrial Fibrillation; Hemorrhage

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Shaw, MD, MSc, FRCPC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Shaw, MD, MSc, FRCPC

CONTACT

613-737-8899; josshaw@ohri.ca

Marc Carrier, MD

CONTACT

6137378899; mcarrier@toh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 28, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: February 6, 2026

Record last verified: 2026-02