BridgeMD
New treatment option for Venous Thromboembolism
Official title Apixaban or Enoxaparin After Head and Neck Cancer Surgery
ClinicalTrials.gov ID: NCT07189897
What this study is testing
What is Enoxaparin?
Enoxaparin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for venous thromboembolism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- 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).
You likely can't join if
- 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)...
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Syracuse, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Syracuse, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.