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

NCT00814333

Last updated date
Study Location
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Epistaxis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- English speaking adults that have failed first line therapy for anterior epistaxis in the ER or the hospital

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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EpistaxisTrial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
NCT00814333
  1. Kansas City, Kansas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
Official Title  ICMJE A Randomized Controlled Trial Comparing Outcomes in Patients Treated With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epistaxis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Thrombin-JMI
    Intervention: Drug: Thrombin-JMI
  • Active Comparator: 2
    Merocel pack
    Intervention: Drug: Merocel pack
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 28, 2013)
1
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2008)
50
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00814333
Other Study ID Numbers  ICMJE 11564
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Keith Sale, MD, University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Keith Sale, MDUniversity of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date December 2015

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