Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis

Epistaxis Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Outcomes in Patients Treated With Merocel Packing or Thrombin-JMI for Anterior Epistaxis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00814333
• Other study ID #: 11564
• Status: Terminated
• Phase: N/A
• First received: December 23, 2008
• Last updated: December 10, 2015
• Start date: December 2008
• Est. completion date: August 2011

Study information

• Verified date: December 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epistaxis

Intervention

Drug:
• Thrombin-JMI
5,000 IU, to nasal mucosa via syringe spray applicator
• Merocel pack
8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cessation of Epistaxis		baseline, day 4-6	No