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

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ClinicalTrials.gov Identifier: NCT00814333
Recruitment Status : Terminated (Product supplier change - bought out. Unable to enroll patients.)
First Posted : December 24, 2008
Results First Posted : January 15, 2016
Last Update Posted : January 15, 2016
Sponsor:
Collaborator:
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Keith Sale, MD, University of Kansas Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Epistaxis Drug: Thrombin-JMI Drug: Merocel pack Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
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
Study Start Date : December 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
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Principal Investigator: Keith Sale, MD University of Kansas Medical Center
More Information
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Responsible Party: Keith Sale, MD, Associate Professor & Vice Chairman, Otolaryngology, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00814333    
Other Study ID Numbers: 11564
First Posted: December 24, 2008    Key Record Dates
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:
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Epistaxis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
 Signs and Symptoms, Respiratory
Thrombin
Polyvinyl alcohol formaldehyde foam
Hemostatics
Coagulants