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

This study is currently recruiting participants.

Verified by University of Kansas, September 2009

First Received: December 23, 2008 Last Updated: September 18, 2009 History of Changes

Sponsor:	University of Kansas
Collaborator:	King Pharmaceuticals
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00814333

Purpose

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.

Condition	Intervention
Epistaxis	Drug: Thrombin-JMI Drug: Merocel pack

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Controlled Trial Comparing Outcomes in Patients Treated With Merocel Packing or Thrombin-JMI for Anterior Epistaxis

Resource links provided by NLM:

Drug Information available for: Thrombin alfa

U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:

cessation of epistaxis [ Time Frame: baseline, day 4-6 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	December 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Thrombin-JMI	Drug: Thrombin-JMI 5,000 IU, to nasal mucosa via syringe spray applicator
2: Active Comparator Merocel pack	Drug: Merocel pack 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814333

Contacts

Contact: Kevin Sykes

913-588-7318

ksykes@kumc.edu

Locations

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

Sponsors and Collaborators

University of Kansas

King Pharmaceuticals

Investigators

Principal Investigator:

Keith Sale, MD

University of Kansas

More Information

No publications provided

Responsible Party:	University of Kansas Medical Center ( Keith Sale MD )
Study ID Numbers:	11564
Study First Received:	December 23, 2008
Last Updated:	September 18, 2009
ClinicalTrials.gov Identifier:	NCT00814333 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

epistaxis

Additional relevant MeSH terms:

Thrombin
Polyvinyl alcohol formaldehyde foam
Otorhinolaryngologic Diseases
Coagulants
Epistaxis
Hematologic Agents
Hemorrhage

Nose Diseases
Hemostatics
Pharmacologic Actions
Pathologic Processes
Respiratory Tract Diseases
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2010