A Randomized Controlled Trial Comparing Outcomes in Patients Treated With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Cessation of Epistaxis
Study Overview
Brief Summary
Epistaxis is a common problem among people of all ages and backgrounds. However, occasionally epistaxis can be severe enough to require emergency room admission. Among the treatment options for epistaxis, nasal packing is the most common approach. This approach requires a return visit to the clinic for removal of the packing. Additionally, there is a great deal of pain during the insertion and removal of this packing. This study aims to justify the further investigation of thrombin as a potential treatment approach for these patients. Thrombin could provide a treatment approach that reduces pain and eliminates the need for a return visit to the clinic.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •English speaking adults that have failed first line therapy for anterior epistaxis in the ER or the hospital
Exclusion Criteria
- •Non-english speaking patients
- •Patients with bleeding disorders
- •Known pregnant women or women that think they may be pregnant
- •Patients with a know presence of antibodies to bovine thrombin preparations
- •Patients that currently have or are known to have a history of systemic skin condition or rash such as eczema or psoriasis
- •Patients found to have posterior epistaxis
- •Patients requiring a surrogate for medical decisions
Arms & Interventions
1
Thrombin-JMI
Intervention: Thrombin-JMI (Drug)
2
Merocel pack
Intervention: Merocel pack (Drug)
Outcomes
Primary Outcomes
Cessation of Epistaxis
Time Frame: baseline, day 4-6
Secondary Outcomes
No secondary outcomes reported
Investigators
Keith Sale, MD
Associate Professor & Vice Chairman, Otolaryngology
University of Kansas Medical Center