Extended Prophylactic Anticoagulation Following Spinal Surgery for Metastatic Disease

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

First listed

Jul 20, 2026

Start date

Aug 31, 2026

Status verified

Jul 2026

Primary completion

Nov 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Extended Prophylactic Anticoagulation
  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.

Primary Outcome Measure

Incidence of Symptomatic Venous Thromboembolism (VTE) [ Time Frame: Time Frame: Within 90 days of hospital discharge ]

Central Contacts

• James Bayley, MD
  412-623-7073
  [email protected]

Locations (3)

Find similar trials in Pittburgh, PA

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