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

December 10, 2015 updated by: Keith Sale, MD, University of Kansas Medical Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cessation of Epistaxis
Time Frame: baseline, day 4-6
baseline, day 4-6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Keith Sale, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

December 23, 2008

First Submitted That Met QC Criteria

December 23, 2008

First Posted (Estimate)

December 24, 2008

Study Record Updates

Last Update Posted (Estimate)

January 15, 2016

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11564 (DAIDS ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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