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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • standardized perioperative anticoagulation management Guideline

    Other intervention

    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).

Treatment groups

700 Participants
are divided into 1 treatment group
Group A: study interventionOther 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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
2

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
3

30-day risk of all-cause mortality

Death from any cause within 30 days post-surgery

Time frame
30 days
4

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.

Other outcomes

Sponsors and contacts

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