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Not yet recruitingPhase 4

Extended Prophylactic Anticoagulation Following Spinal Surgery for Metastatic Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks, 30 days
  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Participants will take apixaban for 30 days starting the day after hospital discharge."
  • "This is a single-arm, prospective, open-label interventional pilot study evaluating extended prophylactic anticoagulation with apixaban 2.5 mg orally twice daily for 30 days following hospital discharge."
  • "Additional secondary endpoints include medication adherence (pill count at Day 31), spinal epidural hematoma requiring intervention, hospital readmission rates, and emergency department visits within 90 days."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether apixaban (Eliquis), a blood thinner, helps prevent blood clots after spine surgery for cancer that has spread to the spine. Adults at UPMC will take it for 30 days after leaving the hospital. The study will also check for bleeding and other side effects.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Had surgery for cancer that spread to the spine at UPMC Presbyterian, Shadyside, or Mercy Hospital.
  • Plan to leave the hospital for home or an acute rehab center, not hospice.
  • Willing and able to sign a form agreeing to join the study.
  • Able to take medicine by mouth.
  • Have access to a phone for follow-up calls.

Who can't join

  • Already take treatment-dose blood thinners for another health problem, or plan to start them within 30 days.
  • Have an allergy to apixaban, current bleeding, or a history of serious bleeding, such as bleeding in the brain or recent serious bleeding in the stomach or intestines.
  • Have certain low blood cell counts, abnormal kidney or liver blood tests, or severe liver disease.
  • Are pregnant or breastfeeding, or could become pregnant but will not use birth control during the study.
  • Had part or all of the stomach or the upper small intestine removed, which may affect how the body takes in medicine.
  • Take medicines that can interfere with apixaban; cannot safely stop medicines such as aspirin or clopidogrel; or cannot or will not stop regular NSAID pain medicine use for 30 days. As-needed NSAID use fewer than 3 days a week is allowed.
  • Plan to have surgery or another procedure that enters the body within 30 days, or have stayed in the hospital for 30 days or longer.
  • Are in prison or jail, or have another condition the study doctor believes makes joining unsafe or prevents following study steps.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (3)

PA