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

NCT ID: NCT00814333

Last Updated: 2016-01-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-08-31

Brief Summary

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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

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Conditions

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Epistaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Thrombin-JMI

Group Type EXPERIMENTAL

Thrombin-JMI

Intervention Type DRUG

5,000 IU, to nasal mucosa via syringe spray applicator

2

Merocel pack

Group Type ACTIVE_COMPARATOR

Merocel pack

Intervention Type DRUG

8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps

Interventions

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Thrombin-JMI

5,000 IU, to nasal mucosa via syringe spray applicator

Intervention Type DRUG

Merocel pack

8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Keith Sale, MD

Associate Professor & Vice Chairman, Otolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keith Sale, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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11564

Identifier Type: -

Identifier Source: org_study_id

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