Extended Prophylactic Anticoagulation Following Spinal Surgery for Metastatic Disease

NCT07713875 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY25120085
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Venous Thromboembolism (VTE); Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE); Spine Metastasis

Keywords

Apixaban; Eliquis; Extended thromboprophylaxis; Postoperative anticoagulation; Spine surgery; Cancer surgery; VTE prophylaxis; Direct oral anticoagulant; DOAC; Factor Xa inhibitor; Metastatic bone disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Time Frame: Within 90 days of hospital discharge

Secondary Outcomes (6)

• Incidence of Major Bleeding Events

  Within 90 days of hospital discharge

• Incidence of Clinically Relevant Non-Major Bleeding Events

  Within 90 days of hospital discharge

• Medication Adherence

  Day 31 post-discharge

• Incidence of Spinal Epidural Hematoma Requiring Intervention

  Within 90 days of hospital discharge

• Hospital Readmission Rate

  Within 90 days of hospital discharge

Study Arms (1)

Extended Prophylactic Anticoagulation

EXPERIMENTAL

Apixaban 2.5 mg orally twice daily for 30 days beginning the day after hospital discharge following spinal surgery for metastatic disease. Participants also receive standard inpatient VTE prophylaxis (subcutaneous heparin or enoxaparin) from postoperative day 1 through discharge, per routine clinical care.

Drug: Apixaban

Interventions

Apixaban DRUG

Apixaban 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.

Also known as: Eliquis

Extended Prophylactic Anticoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• James Bayley: lead
• The Greg Beckwith Foundation: collaborator

Study Sites (3)

UPMC Presbyterian Hospital

Pittburgh, Pennsylvania, 15213, United States

Location

UPMC Shadyside Hospital

Pittburgh, Pennsylvania, 15232, United States

Location

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (13)

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MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism; Bone Diseases

Interventions

apixaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism; Musculoskeletal Diseases

Central Study Contacts

James Bayley, MD

CONTACT

412-623-7073; bayleyjc2@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Neurosurgery

Model Details: Single-arm, prospective, open-label interventional study. All enrolled participants receive apixaban 2.5 mg orally twice daily for 30 days following hospital discharge after spinal surgery for metastatic disease. Outcomes are compared to a historical control cohort of 68 patients who underwent the same type of surgery but did not receive extended prophylactic anticoagulation after discharge. The historical cohort is not a randomized arm; data were collected retrospectively via medical record review.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 20, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)