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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 : November 1, 2019
Sponsor:
Collaborator:
American Rhinologic Society
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE July 1, 2011
First Posted Date  ICMJE August 3, 2011
Results First Submitted Date  ICMJE December 16, 2015
Results First Posted Date  ICMJE April 20, 2018
Last Update Posted Date November 1, 2019
Study Start Date  ICMJE February 2011
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
Severityof Epistaxis [ Time Frame: Change from Baseline to 14 weeks ]
The primary outcome measure will be severity of epistaxis as measured by the Epistaxis Severity Score (ESS). The ESS, a recently developed online questionarrie that calculates the grading system for epistaxis severity. The higher the score the more severe the nose bleeds are Scale consists of several questions with a range of scale from 0-5 The average score is calculated for a final assessment
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
Frequency and severity of epistaxis [ Time Frame: Baseline (pre-treatment), at 3 months after baseline visit and at 6 months after baseline visit. ]
The primary outcome measure will be frequency and severity of epistaxis as measured by the Epistaxis Severity Score (ESS). The ESS, a recently developed grading system for epistaxis severity, has been recommended for comparison of existing and new therapies for epistaxis. The ESS was reported to be an accurate, reproducible, validated objective measure of epistaxis severity. The ESS will be measured at baseline in both treatment groups, and at the end of the first and second periods. Monthly diaries will be kept to aid in accuracy of reporting the ESS.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
  • Hemoglobin level [ Time Frame: Baseline ]
    Blood exams will be performed to assess subject's hemoglobin level.
  • Tolerability of sclerotherapy [ Time Frame: Baseline (pre-treatment), at 3 months after baseline visit and at 6 months after baseline visit. ]
    Tolerability of sclerotherapy will be measured through patient administered questionnaires after the sclerotherapy procedure.
  • Patient's need for additional treatment [ Time Frame: At 3 and 6 month follow-up visits and any additional visit, if needed, between this time frame ]
    Patient's need for additional treatment besides sclerotherapy will be measured through patient request for extra treatment, and degree of blood loss during epistaxis.
  • Overall quality of life [ Time Frame: Baseline (pre-treatment), at 3 months after baseline visit and at 6 months after baseline visit. ]
    Quality of life will be measured using the SF-12 instrument. This will be collected at the end of each 3 month interval.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia
Official Title  ICMJE Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia
Brief Summary The purpose of this study is to test a novel and tolerable office-based treatment method, sclerotherapy with sodium tetradecyl sulfate, for recurrent epistaxis (nosebleeds) related to Hereditary Hemorrhagic Telangiectasia (HHT) disease.
Detailed Description

Ninety percent of patients who suffer from Hereditary Hemorrhagic Telangiectasia (HHT) experience epistaxis which can range from mild to recurrent, severe, life threatening episodes. Current methods to treat significant epistaxis have limitations, namely the need for general anesthesia and repeated treatments. The objective of this study is to test a novel and tolerable office-based treatment method, sclerotherapy with sodium tetradecyl sulfate (STS), for recurrent epistaxis related to HHT.

Sclerotherapy is the treatment of vascular lesions by injection with an agent which causes thickening of the vessel wall, obstruction of blood flow, clot formation and collapse of the lesion. Sclerotherapy is an established treatment modality for vascular malformations in the skin, GI tract, genitourinary tract and has been used for lesions in various sites in the head and neck. STS is an anion surfactant (detergent) that is commonly used for sclerotherapy. There are case reports in the literature describing sclerotherapy treatments for epistaxis related to HHT using other agents, but these case reports did not lead to prospective studies. We have performed a pilot study to analyze the tolerability and effectiveness of sclerotherapy with STS in a series of patients with recurrent epistaxis related to HHT. In our series, the treatment was found to be well tolerated and effective, based on patient administered questionnaire and review of clinical data. No complications related to the procedure were noted. Further prospective studies would help elucidate the role of sclerotherapy with STS in the treatment algorithm for recurrent epistaxis related to HHT.

Our goal is to conduct a prospective, randomized-controlled trial to test the efficacy and tolerability of sclerotherapy using STS in the treatment of recurrent epistaxis due to HHT. A modified crossover design will be utilized with the intervention group receiving sclerotherapy, plus any additional, previously utilized standard treatment methods needed to control epistaxis. The control group will receive their current standard treatment methods, followed by delayed intervention with sclerotherapy. The primary outcomes will be frequency and severity of epistaxis. Secondary endpoints will be hemoglobin level, tolerability of treatment, additional treatment requirements, and quality of life.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Epistaxis
  • Hereditary Hemorrhagic Telangiectasia
Intervention  ICMJE
  • Drug: Sclerotherapy
    3% Sodium tetradecyl sulfate (STS) is mixed with air at a ratio of 4 parts air to 1 part STS for injection into the affected vessels in the nose. Topical anesthetic is applied to the nasal mucosa prior to injections. Once the mixture is ready for injection, the needle is placed into the vessel, in a submucosal fashion, penetrating 1-2 mm, and very small quantities of foam are injected The amount of foam injected into each lesion varies between 0.1 cc to 0.25 cc. Individual injection amounts vary between lesions, patients and treatment sessions. No more than a total of 3 ml of solution is used in each session. During each session, several lesions can be treated, but the total amount of STS used does not exceed 3 cc.
    Other Name: Sotradecol
  • Other: Standard Treatment
    Normal standard of care followed by Drug interevention
Study Arms  ICMJE
  • Experimental: Standard Treatment then Sclerotherapy Intervention
    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
    Interventions:
    • Drug: Sclerotherapy
    • Other: Standard Treatment
  • Experimental: Sclerotherapy Intervention then Standard Treatment'
    This group will receive, on the first 6 weeks 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. On the second 6 weeks of the study this group will continue with standard treatments that they had been receiving for epistaxis prior to the study. Wash out period of two weeks
    Interventions:
    • Drug: Sclerotherapy
    • Other: Standard Treatment
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2018)
18
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2011)
38
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • a clinical diagnosis of HHT based on the Curacoa Criteria
  • age 18 and older
  • cognitive ability and willingness to sign the study consent form and complete the study forms and questionnaires

Exclusion Criteria:

  • previous sclerotherapy with Sodium Tetradecyl Sulfate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 NCT01408732
Other Study ID Numbers  ICMJE 1101M95232
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE American Rhinologic Society
Investigators  ICMJE
Principal Investigator: Holly Boyer, MD University of Minnesota
PRS Account University of Minnesota
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP