Safety of perioperative blood thinner management in people with cancer undergoing surgery or procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines perioperative anticoagulation management in cancer patients undergoing surgery or procedures. It aims to describe bleeding and thrombotic events under contemporary practice and to evaluate residual anticoagulant activity at the time of surgery. The study will use a standardized guideline to manage anticoagulation and assess safety outcomes to inform future care. Eligible participants are adults on DOACs, warfarin, or LMWH for AF or VTE with active cancer, enrolled at The Ottawa Hospital under the Ottawa Hospital Research Institute. The goal is to determine whether current perioperative strategies can be safely applied to cancer patients and to identify factors associated with better or worse bleeding and clotting outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• The Ottawa Hospital
  Ottawa, Canada Recruiting

Study contacts

• Principal investigator: Joseph Shaw, MD, MSc, FRCPC — Ottawa Hospital Research Institute
• Study coordinator: Joseph Shaw, MD, MSc, FRCPC
• Email: josshaw@ohri.ca
• Phone: 613-737-8899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.