Atrial Fibrillation (AF), Bleeding, Cancer, Thrombosis, Thrombosis, Deep Vein, Venous Thromboembolic Event
Conditions
Keywords
thrombosis, Atrial fibrillation, Cancer, Anticoagulant Interruption, VTE, bleeding
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.
Interventions
OTHERstandardized 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).
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major bleeding events | 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
| Measure | Time frame | Description |
|---|---|---|
| 30-day combined risk of ATE (Arterial Thromboembolism ) /VTE (Venous Thromboembolism) | 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. |
| 30-day risk of clinically relevant non-major bleeding (ISTH definition) | 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. |
| 30-day risk of all-cause mortality | 30 days | Death from any cause within 30 days post-surgery |
| Time to resumption of anticoagulation (therapeutic dosing) | hours from surgery to administration of therapeutic anticoagulant dose. | Measured in hours from surgery to administration of therapeutic anticoagulant dose. |
| Pre-operative residual anticoagulant levels | Perioperative/Periprocedural | Measured at Visit #3 prior to surgery using drug-specific assays. |
| Pre-operative thrombin generation assay (TGA) parameters | Perioperative/Periprocedural | Lag Time (in minutes) |
Countries
Canada
Contacts
CONTACTJoseph Shaw, MD, MSc, FRCPC
CONTACTMarc Carrier, MD
PRINCIPAL_INVESTIGATORJoseph Shaw, MD, MSc, FRCPC
Ottawa Hospital Research Institute
Outcome results
None listed