Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
Information source: University of Kansas
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epistaxis
Intervention: Thrombin-JMI (Drug); Merocel pack (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Kansas Official(s) and/or principal investigator(s):
Keith Sale, MD, Principal Investigator, Affiliation: University of Kansas
Overall contact:
Kevin Sykes, Phone: 913-588-7318, Email: ksykes@kumc.edu
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.
Clinical Details
Official title: A Randomized Controlled Trial Comparing Outcomes in Patients Treated With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: cessation of epistaxis
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Kevin Sykes, Phone: 913-588-7318, Email: ksykes@kumc.edu
University of Kansas Medical Center, Kansas City, Kansas 66160, United States; Recruiting
Additional Information
Starting date: December 2008
Last updated: March 29, 2010
|
