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

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University of Kansas

Status

Terminated

Conditions

Epistaxis

Treatments

Drug: Merocel pack
Drug: Thrombin-JMI

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00814333
11564 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1 participants in 2 patient groups

1
Experimental group
Description:
Thrombin-JMI
Treatment:
Drug: Thrombin-JMI
2
Active Comparator group
Description:
Merocel pack
Treatment:
Drug: Merocel pack

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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