People who have surgery on their spine to treat cancer that has spread (metastatic disease) have a high chance of developing dangerous blood clots in the legs or lungs. These blood clots are called deep vein thrombosis (DVT) or pulmonary embolism (PE). In a review of patients at UPMC who had this type of surgery, about 15 out of 100 developed a blood clot within 90 days of leaving the hospital.
Right now, patients receive blood-thinning medicine only while they are in the hospital after surgery. Once they go home, the medicine is stopped. There are no guidelines telling doctors whether blood-thinning medicine should continue after patients go home from spine surgery for cancer. However, for other types of major cancer surgery, studies have shown that continuing blood-thinning medicine for about 4 weeks after surgery can help prevent blood clots.
This study will test whether taking a blood-thinning medicine called apixaban (brand name Eliquis) by mouth for 30 days after leaving the hospital can help prevent blood clots in patients who have had spine surgery for cancer that has spread. The dose used in this study (2.5 mg twice a day) is the same dose approved by the U.S. Food and Drug Administration (FDA) for preventing blood clots after hip and knee replacement surgery.
About 50 adults at UPMC will take part. Participants will take apixaban for 30 days starting the day after hospital discharge. The study team will call participants by phone three times - about 2 days, 31 days, and 91 days after discharge - to check on their health, ask about any bleeding or blood clot symptoms, and assess medication use. No extra clinic visits are required. Results will be compared to a group of 68 patients who had the same type of surgery in the past but did not take apixaban after leaving the hospital.
The main goal is to find out if apixaban reduces the rate of blood clots within 90 days of hospital discharge. The study will also track bleeding events and other side effects to determine if this approach is safe. The study hypothesis is that extended blood-thinning medicine after surgery will reduce blood clots compared to the current approach of stopping this medicine at hospital discharge.
Age 18 years or older
Undergone spinal surgery (any approach) for treatment of vertebral metastatic disease at UPMC Presbyterian, Shadyside, or Mercy Hospital
Planned for discharge to home or acute rehabilitation facility (not hospice)
Willing and able to provide written informed consent
Already receiving therapeutic anticoagulation for another indication (e.g., atrial fibrillation, prior VTE, mechanical heart valve)
Planned initiation of therapeutic anticoagulation within the next 30 days for another indication
Known allergy or hypersensitivity to apixaban
History of pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding requiring transfusion or endoscopic intervention within the past 6 months)
Single group
Apixaban
DrugApixaban 2.5 mg tablet taken orally twice daily (morning and evening) for 30 days, starting the day after hospital discharge. This is the FDA-approved prophylactic dose for VTE prevention following hip and knee replacement surgery.
Incidence of Symptomatic Venous Thromboembolism (VTE)
Number of participants who develop symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism (PE), confirmed by imaging (compression ultrasound, CT pulmonary angiogram, or V/Q scan) or adjudicated by clinical criteria per protocol-defined definitions.
Incidence of Major Bleeding Events
Number of participants experiencing major bleeding as defined by International Society on Thrombosis and Haemostasis (ISTH) criteria: fatal bleeding, bleeding in a critical organ, bleeding causing hemoglobin drop ≥2 g/dL, or bleeding requiring transfusion of ≥2 units of packed red blood cells.
Incidence of Clinically Relevant Non-Major Bleeding Events
Number of participants experiencing clinically relevant non-major (CRNM) bleeding as defined by ISTH criteria: overt bleeding not meeting major bleeding criteria but requiring medical intervention, unscheduled physician contact, temporary cessation of study drug, or causing impairment of daily activities.
Medication Adherence
Proportion of participants achieving ≥80% adherence based on self-reported pill count at Day 31. Adherence calculated as (60 minus remaining pills) divided by 60.
Incidence of Spinal Epidural Hematoma Requiring Intervention
Number of participants who develop spinal epidural hematoma requiring surgical intervention.
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