NCT07713875Not yet recruitingPhase 4
Extended Prophylactic Anticoagulation Following Spinal Surgery for Metastatic Disease
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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 (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 14 Jul 2026
- Start date
- Aug 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- James Bayley
- NCT number
- NCT07713875
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From Aug 2026 to the primary completion date, Nov 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Already receiving therapeutic anticoagulation for another indication (e.g., atrial fibrillation, prior VTE, mechanical heart valve)
- 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
Other illness
- 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
- Known severe hepatic impairment (Child-Pugh Class C)
- History of proximal gastrointestinal resection (i.e., gastrectomy and/or proximal small bowel resection) that might alter oral drug absorption
- Any other condition that, in the investigator's opinion, would make the subject unsuitable for study participation or unable to comply with study procedures
Lab values
- 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
Other
- Planned initiation of therapeutic anticoagulation within the next 30 days for another indication
- Pregnancy or breastfeeding
- Women of childbearing potential unwilling to use adequate contraception during study participation
- Hospital length of stay 30 days or greater
- Prisoner or incarcerated individual
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UPMC Shadyside Hospital Coordinator of this site? Confirm its status | Pittburgh | United States | Unknown status |
| UPMC Presbyterian Hospital Coordinator of this site? Confirm its status | Pittburgh | United States | Unknown status |
| UPMC-Mercy Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.