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NCT Number: NCT07372716

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

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Key information

Conditions

Thrombosis Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation (AF) Bleeding Cancer Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Hemorrhage Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis, Deep Vein Vascular Diseases Venous Thromboembolic Event Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Major bleeding events

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

    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

  1. 30-day combined risk of ATE (Arterial Thromboembolism ) /VTE (Venous Thromboembolism)

    Time frame: 30 days

    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.

  2. 30-day risk of clinically relevant non-major bleeding (ISTH definition)

    Time frame: 30 days

    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.

  3. 30-day risk of all-cause mortality

    Time frame: 30 days

    Death from any cause within 30 days post-surgery

  4. Time to resumption of anticoagulation (therapeutic dosing)

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

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

  5. Pre-operative residual anticoagulant levels

    Time frame: Perioperative/Periprocedural

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

  6. Pre-operative thrombin generation assay (TGA) parameters

    Time frame: Perioperative/Periprocedural

    Lag Time (in minutes)

  7. Pre-operative thrombin generation assay (TGA) parameters

    Time frame: Perioperative/Periprocedural

    Time to Peak (in minutes)

  8. Pre-operative thrombin generation assay (TGA) parameters

    Time frame: Perioperative/Periprocedural

    Peak thrombin generation (peak; in nM)

  9. Pre-operative thrombin generation assay (TGA) parameters

    Time frame: Perioperative/Periprocedural

    Endogenous thrombin potential (ETP; in nM/min)

  10. Pre-operative thrombin generation assay (TGA) parameters

    Time frame: Perioperative/Periprocedural

    Mean velocity rate index (mVRI; in nM/min).

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph Shaw, MD, MSc, FRCPC

CONTACT

[email protected]

613-737-8899 ext. 74630

Marc Carrier, MD

CONTACT

[email protected]

6137378899

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

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

Acronym: ACE-HIGH

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jan 28, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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