Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
NCT00814333
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Epistaxis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- English speaking adults that have failed first line therapy for anterior epistaxis in the ER or the hospital
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
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EpistaxisTrial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
NCT00814333
- Kansas City, Kansas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis | |||
| Official Title ICMJE | A Randomized Controlled Trial Comparing Outcomes in Patients Treated With Merocel Packing or Thrombin-JMI for Anterior Epistaxis | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Not Applicable | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Epistaxis | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Actual Enrollment ICMJE | 1 | |||
| Original Estimated Enrollment ICMJE | 50 | |||
| Actual Study Completion Date ICMJE | August 2011 | |||
| Actual Primary Completion Date | August 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00814333 | |||
| Other Study ID Numbers ICMJE | 11564 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Keith Sale, MD, University of Kansas Medical Center | |||
| Study Sponsor ICMJE | University of Kansas Medical Center | |||
| Collaborators ICMJE | King Pharmaceuticals is now a wholly owned subsidiary of Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | University of Kansas Medical Center | |||
| Verification Date | December 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||