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

This study has been terminated.
(Product supplier change - bought out. Unable to enroll patients.)
Sponsor:
Collaborator:
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Keith Sale, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT00814333
First received: December 23, 2008
Last updated: December 10, 2015
Last verified: December 2015
Results First Received: December 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epistaxis
Interventions: Drug: Thrombin-JMI
Drug: Merocel pack

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Merocel Pack

Standard of care for persons being treated for epistaxis.

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

Thrombin-JMI Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator

Participant Flow for 2 periods

Period 1:   Enrollment
    Merocel Pack     Thrombin-JMI  
STARTED     1     0  
COMPLETED     0     0  
NOT COMPLETED     1     0  
Lost to Follow-up                 1                 0  

Period 2:   Treatment Period
    Merocel Pack     Thrombin-JMI  
STARTED     0     0  
COMPLETED     0     0  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Merocel Pack

Standard of care for persons being treated for epistaxis.

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

Thrombin-JMI Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
Total Total of all reporting groups

Baseline Measures
    Merocel Pack     Thrombin-JMI     Total  
Number of Participants  
[units: participants]
  1     0     1  
Age  
[units: participants]
     
<=18 years     0         0  
Between 18 and 65 years     1         1  
>=65 years     0         0  
Gender  
[units: participants]
     
Female     0         0  
Male     1         1  
Region of Enrollment  
[units: participants]
     
United States     1         1  



  Outcome Measures

1.  Primary:   Cessation of Epistaxis   [ Time Frame: baseline, day 4-6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kevin Sykes, PhD
Organization: University of Kansas Medical Center
phone: 913-588-7154
e-mail: ksykes@kumc.edu



Responsible Party: Keith Sale, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00814333     History of Changes
Other Study ID Numbers: 11564
Study First Received: December 23, 2008
Results First Received: December 10, 2015
Last Updated: December 10, 2015
Health Authority: United States: Institutional Review Board