Clinical Trial: Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:

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 mod
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome:

• Frequency of epistaxis [ Time Frame: Baseline (pre-treatment), at 6 weeks after baseline visit and at 12 weeks 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.
• Severity of epistaxis [ Time Frame: Baseline (pre-treatment), at 6 weeks after baseline visit and at 12 weeks after baseline visit. ]
  Severity of epistaxis will be 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.

Original Primary Outcome: Frequency and severity of epistaxis [ Time Frame: Baseline (pre-treatment), at 3 months after baseline visit and at 6 months after baseline visit. ]

Current Secondary Outcome:

• 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 6 weeks after baseline visit and at 12 weeks 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 6 and 12 weeks 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 6 weeks after baseline visit and at 12 weeks 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.

Original Secondary Outcome:

• 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.

Dates:
Date Received: July 1, 2011
Date Started: February 2011
Date Completion:
Last Updated: October 9, 2014
Last Verified: October 2014