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NCT07713875

Overview

NCT ID: NCT07713875
Lead Sponsor: James BayleyOTHER
Official Title: Extended Prophylactic Anticoagulation Following Spinal Surgery for Metastatic Disease
Brief Summary: 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 20, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Nov 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Able to take oral medications

Access to a telephone for follow-up calls

Exclusion Criteria:

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)

Active bleeding at time of planned enrollment

Platelet count less than 50,000/mm³ at time of enrollment

Hemoglobin less than 8 g/dL at time of enrollment

Serum creatinine greater than 2.5 mg/dL

ALT or AST greater than 3 times the upper limit of normal

Total bilirubin greater than 2 times the upper limit of normal

Known severe hepatic impairment (Child-Pugh Class C)

Pregnancy or breastfeeding

Women of childbearing potential unwilling to use adequate contraception during study participation

History of proximal gastrointestinal resection (i.e., gastrectomy and/or proximal small bowel resection) that might alter oral drug absorption

Concurrent use of strong dual inhibitors of CYP3A4 and P-gp or moderate CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin, diltiazem)

Concurrent use of strong dual inducers of CYP3A4 and P-gp (rifampin, carbamazepine, phenytoin, St. John's Wort)

Inability to safely discontinue all antiplatelet medications for the 30-day study drug period, as determined by the treating cardiologist or prescribing physician (aspirin, clopidogrel, ticagrelor)

Inability or unwillingness to discontinue chronic NSAID use during the 30-day study drug period (as-needed use less than 3 days per week is acceptable)

Planned surgery or invasive procedure within the next 30 days

Hospital length of stay 30 days or greater

Prisoner or incarcerated individual

Any other condition that, in the investigator's opinion, would make the subject unsuitable for study participation or unable to comply with study procedures

Study Plan

Study Type: Interventional
Phase: Phase 4
Enrollment: 50Estimated
Primary Purpose: Prevention
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: James Bayley, MDContact
bayleyjc2@upmc.edu412-623-7073

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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