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

This study has been terminated.
(Product supplier change - bought out. Unable to enroll patients.)
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Keith Sale, MD, University of Kansas Medical Center Identifier:
First received: December 23, 2008
Last updated: December 10, 2015
Last verified: December 2015
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.

Condition Intervention
Drug: Thrombin-JMI
Drug: Merocel pack

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Outcomes in Patients Treated With Merocel Packing or Thrombin-JMI for Anterior Epistaxis

Resource links provided by NLM:

Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Cessation of Epistaxis [ Time Frame: baseline, day 4-6 ]

Enrollment: 1
Study Start Date: December 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Thrombin-JMI
5,000 IU, to nasal mucosa via syringe spray applicator
Active Comparator: 2
Merocel pack
Drug: Merocel pack
8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00814333

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Principal Investigator: Keith Sale, MD University of Kansas Medical Center
  More Information

Responsible Party: Keith Sale, MD, Associate Professor & Vice Chairman, Otolaryngology, University of Kansas Medical Center Identifier: NCT00814333     History of Changes
Other Study ID Numbers: 11564
Study First Received: December 23, 2008
Results First Received: December 10, 2015
Last Updated: December 10, 2015

Keywords provided by University of Kansas Medical Center:

Additional relevant MeSH terms:
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pathologic Processes
Polyvinyl alcohol formaldehyde foam
Anti-Infective Agents processed this record on May 24, 2017