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Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia

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ClinicalTrials.gov Identifier: NCT01408732
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : April 20, 2018
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
American Rhinologic Society
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Epistaxis
Hereditary Hemorrhagic Telangiectasia
Interventions: Drug: Sclerotherapy
Other: Standard Treatment

  Participant Flow

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
Each group will get the same therapy in a different order Total number of subjects 18 with 2 incompletes. First period is 6 weeks with a 2 week washout period and 2 period is 6 weeks

Reporting Groups
  Description
Sclerotherapy Intervention Then Standard Treatment This group will receive, on the first period of the study, sclerotherapy with STS to any visible lesions in the nose at the outset, followed by any needed standard treatments for breakthrough epistaxis. Washout period of 2 weeks
Standard Treatment Then Sclerotherapy The standard treatment group will continue their pre-study "standard treatment" methods to treat epistaxis on the first 6 weeks of the study, followed by intervention with sclerotherapy on the second 6 weeks of the study, plus any additionally needed standard treatments for breakthrough epistaxis. Wash out period 2 weeks

Participant Flow:   Overall Study
    Sclerotherapy Intervention Then Standard Treatment   Standard Treatment Then Sclerotherapy
STARTED   9   9 
COMPLETED   7   7 
NOT COMPLETED   2   2 
Withdrawal by Subject                2                2 



  Baseline Characteristics

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
Entire Study Population No text entered.

Baseline Measures
   Entire Study Population 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Years]
Mean (Full Range)
 51.8 
 (31 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  50.0% 
Male      9  50.0% 
Region of Enrollment 
[Units: Participants]
 
United States   18 
Curacao criteria [1] 
[Units: Participants]
 
Visceral Lesions   9 
Family history:   9 
[1]

1. Epistaxis;: spontaneous, recurrent nose bleeds 2. Telangiectases: multiple, at characteristic sites (lips, oral cavity, fingers, nose) 3. Visceral Lesions such as gastrointestinal telangiectasia (with or without bleeding), pulmonary arteriovenous malformation (AVM), hepatic AVM, cerebral AVMs, spinal AVM 4. Family history: a first degree relative with HHT according to these criteria

Diagnosis of HHT Define: 3 criteria are present Possible or suspected: 2 criteria are present Unlikely: <2 criteria are present

(Shovlin et al)

Number of Telangiectasia 
[Units: Telangiectasia]
Mean (Full Range)
 7 
 (3 to 12) 
Telangiectasia type [1] 
[Units: Participants]
 
Type 1   4 
Type 2   13 
Type 3   1 
[1] (I) isolated punctate telangiectasias or individual small arteriovenous malformation; (II) diffuse interconnecting vasculature with "feeder" vessels; and (III) large solitary arteriovenous malformation, which may be associated with scattered telangiectasia (Mahoney and Shapshay)
Prior Treatment 
[Units: Participants]
 
Moisturization   11 
Packing   4 
Cautery   3 


  Outcome Measures

1.  Primary:   Severityof Epistaxis   [ Time Frame: Change from Baseline to 14 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Holly Boyer, MD
Organization: University of Minnesota
phone: 612-725-2000
e-mail: boyer011@umn.edu



Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01408732     History of Changes
Other Study ID Numbers: Sclerotherapy for Epistaxis
First Submitted: July 1, 2011
First Posted: August 3, 2011
Results First Submitted: December 16, 2015
Results First Posted: April 20, 2018
Last Update Posted: May 30, 2018