Apixaban versus enoxaparin to prevent blood clots after head and neck cancer surgery
An Open-label Pilot Study to Evaluate Medication Satisfaction With Apixaban Versus Enoxaparin for Thrombosis Prevention After Head and Neck Cancer Surgery
This compares apixaban pills to daily enoxaparin shots to see if the pill is a safe and easier way to prevent blood clots after head and neck cancer surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | State University of New York - Upstate Medical University Academic / other |
| Locations | 1 site (Syracuse, New York) |
| Trial ID | NCT07189897 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–89 with biopsy-proven or suspected head and neck cancer scheduled for major oncologic head and neck surgery (>45 minutes) who can consent and comply with follow-up are ideal candidates.
Not a fit: People with high bleeding risk, contraindications to anticoagulation, those not undergoing major head and neck surgery, pregnant women, or those unable to attend follow-up visits are unlikely to benefit.
Why it matters
Potential benefit: If apixaban is as safe and effective as enoxaparin, patients could avoid daily injections and have better comfort and adherence without increasing clot or bleeding risk.
How similar studies have performed: Direct oral anticoagulants like apixaban have prevented post-operative clots in orthopedic and other surgical populations, but use after head and neck cancer surgery has been less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Syracuse, New York
- SUNY Upstate — Syracuse, New York, United States (Recruiting)
Study contacts
- Study coordinator: Laine Abernathy, MS
- Email: abernatL@upstate.edu
- Phone: 315-464-5980
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.