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

NCT00814333 | Terminated Results

• 1 other identifier: 11564
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Epistaxis

Keywords

epistaxis

Outcome Measures

Primary Outcomes (1)

• Cessation of Epistaxis

  baseline, day 4-6

Study Arms (2)

1

EXPERIMENTAL

Thrombin-JMI

Drug: Thrombin-JMI

2

ACTIVE COMPARATOR

Merocel pack

Drug: Merocel pack

Interventions

Thrombin-JMI DRUG

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

1

Merocel pack DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• King Pharmaceuticals is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Epistaxis

Interventions

Thrombin

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Results Point of Contact

• Title: Kevin Sykes, PhD
• Organization: University of Kansas Medical Center

ksykes@kumc.edu

913-588-7154

Study Officials

• Keith Sale, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor & Vice Chairman, Otolaryngology

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 24, 2008
• Study Start: December 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 15, 2016
• Results First Posted: January 15, 2016

Record last verified: 2015-12

Locations

US (1)