Apixaban versus enoxaparin to prevent blood clots after head and neck cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults having major head and neck cancer surgery are assigned to take either apixaban pills twice daily or enoxaparin injections once daily for 10 days starting 12–24 hours after surgery. Participants keep a medication diary, return unused medication for adherence checks, and complete short surveys about satisfaction. Safety outcomes such as bleeding and thromboembolic events are monitored and recorded. Researchers compare adherence, patient satisfaction, and rates of blood clots and bleeding between the two groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants must:

* Provide signed and dated informed consent.
* Be willing and able to comply with study procedures and follow-up.
* Be 18-89 years old (male or female).
* Have a negative pregnancy test within 24 hours before surgery (if woman of childbearing potential).
* Have biopsy-proven head and neck cancer, or a suspected cancer awaiting tissue diagnosis (can be confirmed by frozen section at surgery).
* Be scheduled for major inpatient or outpatient oncologic head and neck surgery (defined as \>45 minutes operative time).
* Be an appropriate surgical candidate (adequate performance status).

Eligible diagnoses include (not limited to):

* Squamous cell carcinoma of oral cavity, hypopharynx, larynx, nasal cavity
* Malignancies from major salivary glands
* Non-melanoma skin cancers (squamous cell, basal cell, Merkel cell carcinoma)
* Unknown primary tumors of head and neck

Exclusion Criteria:

Participants cannot:

* Lack a tissue diagnosis of head and neck cancer during the study period.
* Have one of these conditions instead of eligible cancer: Benign disease; Primary thyroid cancer (lower VTE risk); Lymphoma (not primarily surgical); or Melanoma
* Fail to undergo definitive head and neck oncologic surgery (e.g., only diagnostic biopsy).
* Have surgery limited to tissue diagnosis only (e.g., direct laryngoscopy, excisional lymph node biopsy).
* Be unable (patient or caregiver) to administer the study drug.
* Have a positive pregnancy test on the day of surgery.
* Have a known history of prior DVT or PE (since extended anticoagulation would be indicated).
* Have hereditary or acquired bleeding/clotting disorders.
* Have severe renal impairment (CrCl \<30 mL/min).
* Have conditions that, in the investigator's judgment, make study participation unsafe or confound results.

Where it's running

• SUNY Upstate
  Syracuse, New York, United States Recruiting

Study contacts

• Study coordinator: Laine Abernathy, MS
• Email: abernatL@upstate.edu
• Phone: 315-464-5980

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.