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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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00814333
First Posted: December 24, 2008
Last Update Posted: January 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Keith Sale, MD, University of Kansas Medical Center
  Purpose
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
Epistaxis Drug: Thrombin-JMI Drug: Merocel pack

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Keith Sale, MD, 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
Thrombin-JMI
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814333


Locations
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
Investigators
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
ClinicalTrials.gov Identifier: NCT00814333     History of Changes
Other Study ID Numbers: 11564
First Submitted: December 23, 2008
First Posted: December 24, 2008
Results First Submitted: December 10, 2015
Results First Posted: January 15, 2016
Last Update Posted: January 15, 2016
Last Verified: December 2015

Keywords provided by Keith Sale, MD, University of Kansas Medical Center:
epistaxis

Additional relevant MeSH terms:
Epistaxis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
Thrombin
Polyvinyl alcohol formaldehyde foam
Formaldehyde
Hemostatics
Coagulants
Disinfectants
Anti-Infective Agents


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