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

Overview

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.

Full Title of Study: “A Randomized Controlled Trial Comparing Outcomes in Patients Treated With Merocel Packing or Thrombin-JMI for Anterior Epistaxis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2011

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 1
    • Thrombin-JMI
  • Active Comparator: 2
    • Merocel pack

Clinical Trial Outcome Measures

Primary Measures

  • Cessation of Epistaxis
    • Time Frame: baseline, day 4-6

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Kansas Medical Center
  • Collaborator
    • King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
  • Provider of Information About this Clinical Study
    • Principal Investigator: Keith Sale, MD, Associate Professor & Vice Chairman, Otolaryngology – University of Kansas Medical Center
  • Overall Official(s)
    • Keith Sale, MD, Principal Investigator, University of Kansas Medical Center

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