An Open-label Pilot Study to Evaluate Medication Satisfaction With Apixaban Versus Enoxaparin for Thrombosis Prevention After Head and Neck Cancer Surgery
Summary
The goal of this clinical trial is to learn if apixaban (a pill) is a safe and easier alternative to taking enoxaparin (a daily shot) to prevent blood clots after head and neck cancer surgery. It will also learn about side effects of both medicines. The main questions it aims to answer are: Can apixaban be used safely instead of enoxaparin to prevent blood clots after surgery? Do patients find apixaban easier or more satisfying to take than enoxaparin? How well do patients follow the treatment plan with each medicine? Researchers will compare 2 groups: One group will take apixaban (a pill taken twice a day) for 10 days after surgery. The other group will take enoxaparin (a shot given once a day) for 10 days after surgery. Participants will: Take either apixaban or enoxaparin starting 12-24 hours after surgery, for 10 days total Keep a medication diary and bring back unused medicine so the study team can check adherence Complete short surveys about satisfaction with their medicine Have an ultrasound of their legs to check for blood clots 11-14 days after surgery Return for follow-up visits about 40 days and 80 days after surgery for safety checks How long will participation last? About 4 months from surgery through the last follow-up visit.
Arms & interventions
- DrugEnoxaparin
For DVT prophylaxis
- DrugApixaban
For DVT prophylaxis
Outcome measures
Primary
Study enrollment rate.
Enrollment rate will be calculated as the number of participants enrolled, divided by the number of eligible participants, multiplied by 100%.
Time frame: From study start until target enrollment is reached (up to 24 months).
Secondary
Medication satisfaction.
Time frame: Assessed at Day 11-14 after completing 10 days of anticoagulant prophylaxis.
Medication satisfaction.
Time frame: Assessed at Day 11-14 after completing 10 days of anticoagulant prophylaxis.
Eligibility criteria
Study locations (1)
SUNY Upstate
Syracuse, New York, 13210