Recruiting

Blood Thinners

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT07372716

Conditions

Thrombosis

Cancer

Thrombosis, Deep Vein

Atrial Fibrillation (AF)

Venous Thromboembolic Event

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

standardized perioperative anticoagulation management Guideline

Study Details

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

Thrombosis, Deep Vein

Atrial Fibrillation (AF)

Venous Thromboembolic Event

Study ID

NCT07372716

Start date

May 5, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

700 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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).

Interventions

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).

Primary outcome measure

  • Major bleeding events [ Time Frame: From enrollment to the end of study follow ups at 4 weeks" ]

Central Contacts and Locations

Central contacts

Joseph Shaw, MD, MSc, FRCPC

613-737-8899josshaw@ohri.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Canada

Contacts

Dr. Joseph Shaw Principal Investigator

613-737-8899 ext 74630josshaw@toh.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-09-08.