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

Primary Purpose

Epistaxis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thrombin-JMI
Merocel pack
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epistaxis focused on measuring epistaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Thrombin-JMI

Merocel pack

Outcomes

Primary Outcome Measures

Cessation of Epistaxis

Secondary Outcome Measures

Full Information

First Posted
December 23, 2008
Last Updated
December 10, 2015
Sponsor
University of Kansas Medical Center
Collaborators
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00814333
Brief Title
Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
Official Title
A Randomized Controlled Trial Comparing Outcomes in Patients Treated With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Product supplier change - bought out. Unable to enroll patients.
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
Collaborators
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis
Keywords
epistaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Thrombin-JMI
Arm Title
2
Arm Type
Active Comparator
Arm Description
Merocel pack
Intervention Type
Drug
Intervention Name(s)
Thrombin-JMI
Intervention Description
5,000 IU, to nasal mucosa via syringe spray applicator
Intervention Type
Drug
Intervention Name(s)
Merocel pack
Intervention Description
8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps
Primary Outcome Measure Information:
Title
Cessation of Epistaxis
Time Frame
baseline, day 4-6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Sale, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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

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