Epistaxis
Conditions
Keywords
epistaxis
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.
Interventions
DRUGThrombin-JMI
5,000 IU, to nasal mucosa via syringe spray applicator
DRUGMerocel pack
8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps
Sponsors
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cessation of Epistaxis | baseline, day 4-6 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Merocel Pack Standard of care for persons being treated for epistaxis.
Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps | 1 |
| Thrombin-JMI Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Enrollment | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Merocel Pack | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants |
| Age, Categorical >=65 years | 0 participants | 0 participants |
| Age, Categorical Between 18 and 65 years | 1 participants | 1 participants |
| Gender Female | 0 participants | 0 participants |
| Gender Male | 1 participants | 1 participants |
| Region of Enrollment United States | 1 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Cessation of Epistaxis
Time frame: baseline, day 4-6
Population: No participants started treatment on this study. Study was closed before any study related procedures were administered.