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

This study has been terminated.
Sponsor:
Collaborator:
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Keith Sale, MD, University of Kansas
ClinicalTrials.gov Identifier:
NCT00814333
First received: December 23, 2008
Last updated: June 28, 2013
Last verified: June 2013

December 23, 2008
June 28, 2013
December 2008
August 2011   (final data collection date for primary outcome measure)
cessation of epistaxis [ Time Frame: baseline, day 4-6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00814333 on ClinicalTrials.gov Archive Site
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Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
A Randomized Controlled Trial Comparing Outcomes in Patients Treated With Merocel Packing or Thrombin-JMI for Anterior Epistaxis

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Epistaxis
  • 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
  • Experimental: 1
    Thrombin-JMI
    Intervention: Drug: Thrombin-JMI
  • Active Comparator: 2
    Merocel pack
    Intervention: Drug: Merocel pack
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00814333
11564
No
Keith Sale, MD, University of Kansas
University of Kansas
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Principal Investigator: Keith Sale, MD University of Kansas
University of Kansas
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP