Prospective Pilot Study of Floseal for the Treatment of Anterior Epistaxis in Patients With (HHT)

NCT02638012 | Completed Results

• 1 other identifier: 15-057
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Current management strategies for severe and recurrent epistaxis secondary to Hereditary hemorrhagic telangiectasia (HHT) include surgical procedures, and uncomfortable nasal packing, both of which are often only short-term solutions. Floseal® may provide a non-invasive and less painful treatment option for epistaxis in HHT patients. This hemostatic agent has been shown to be an effective intraoperative hemostatic agent in a number of surgical procedures including endoscopic sinus surgery. It has also been shown to be favorable over nasal packing at controlling acute anterior epistaxis. Though the efficacy of using Floseal® for epistaxis in HHT patients has been proven anecdotally in the literature it has yet to be proven in a prospective clinical trial. The results of this pilot study will provide insight into the efficacy of using Floseal® in the management of severe epistaxis in HHT patients and to assist in the development of a full-scale prospective clinical trial.

Conditions

Hereditary Hemorrhagic Telangiectasia (HHT); Epistaxis

Outcome Measures

Primary Outcomes (1)

• Epistaxis Severity Score (ESS)

  Questions include: 1. How often did you typically have nosebleeds during the past one month? 2. How long did each nosebleed typically last for you during the past one month? 3. How would you describe your typical nosebleed intensity during the past one month? 4. Have you sought medical attention outside of this research study for your nosebleeds during the past one month? 5. Are you anemic currently? 6. Have you received a red blood cell transfusion specifically for nosebleeds during the past month? The responses to each of the six questions are assigned a weighted integer that is multiplied by the question's coefficient. These are added to yield the raw score, which is then normalized by dividing by the maximum possible score, then multiplied by 10 to give the normalized score. Range of normalized score is 0 to 10. With 0 representing low severity, and 10 representing high severity.

  Baseline and 1 month

Secondary Outcomes (4)

• Change in Number of Nose Bleeds During One Month Period Following Treatment

  Baseline and 1 month

• Change in Severity Rating of Nose Bleeds During One Month Period Following Treatment

  Baseline and 1 month

• Change in Need for Additional Interventions to Control Epistaxis During One Month Following Floseal® Application

  Baseline and 1 month

• Change in Clinical Assessment of Telangiectases, Crusting, Scarring, and Active Bleeding Sites in the Nasal Cavity Before and One Month Following Treatment

  Baseline and 1 month

Study Arms (1)

HHT - Floseal

EXPERIMENTAL

Once the bleeding has stopped following application of the Floseal® a 50 cc syringe with sterile saline will be used to irrigate the treated nasal cavity to remove any excess Floseal® product as per manufacturer recommendations. This is done with the patient's head tilted downwards at a 30 degree angle so that the irrigation and excess product is removed from the nasal cavity. If bleeding is not controlled after up to two Floseal applications, the gel and clots will be removed with suction, and the patient will be treated with a standard packing treatment (standard of care).

Drug: Floseal; Other: Packing

Interventions

Floseal DRUG

Topical lidocaine spray (2%) is then administered using 1-2 sprays in the affected nasal cavity via the nostril that is to have Floseal® applied. Once the bleeding has stopped following application of the Floseal® a 50 cc syringe with sterile saline will be used to irrigate the treated nasal cavity to remove any excess Floseal® product as per manufacturer recommendations. This is done with the patient's head tilted downwards at a 30 degree angle so that the irrigation and excess product is removed from the nasal cavity. Once the irrigation is complete, the nasal cavity is inspected for evidence of continued bleeding.

Also known as: Floseal hemostatic matrix

HHT - Floseal

Packing OTHER

If bleeding is not controlled after up to two Floseal applications, the gel and clots will be removed with suction, and the patient will be treated with a standard packing treatment (standard of care).

HHT - Floseal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of HHT
• Active anterior epistaxis

You may not qualify if:

• A known sensitivity to any of the materials of Floseal® or the topical medications administered as part of the evaluation and treatment of epistaxis (lidocaine, xylometazoline hydrochloride)
• Pregnant and/or breast feeding woman

Sponsors & Collaborators

• Unity Health Toronto: lead
• The Ottawa Hospital: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (11)

• Sharathkumar AA, Shapiro A. Hereditary haemorrhagic telangiectasia. Haemophilia. 2008 Nov;14(6):1269-80. doi: 10.1111/j.1365-2516.2008.01774.x.

  PMID: 19141168 BACKGROUND

• Olitsky SE. Hereditary hemorrhagic telangiectasia: diagnosis and management. Am Fam Physician. 2010 Oct 1;82(7):785-90.

  PMID: 20879701 BACKGROUND

• Pau H, Carney AS, Murty GE. Hereditary haemorrhagic telangiectasia (Osler-Weber-Rendu syndrome): otorhinolaryngological manifestations. Clin Otolaryngol Allied Sci. 2001 Apr;26(2):93-8. doi: 10.1046/j.1365-2273.2001.00442.x.

  PMID: 11309047 BACKGROUND

• Mathiasen RA, Cruz RM. Prospective, randomized, controlled clinical trial of a novel matrix hemostatic sealant in patients with acute anterior epistaxis. Laryngoscope. 2005 May;115(5):899-902. doi: 10.1097/01.MLG.0000160528.50017.3C.

  PMID: 15867662 BACKGROUND

• Hoag JB, Terry P, Mitchell S, Reh D, Merlo CA. An epistaxis severity score for hereditary hemorrhagic telangiectasia. Laryngoscope. 2010 Apr;120(4):838-43. doi: 10.1002/lary.20818.

  PMID: 20087969 BACKGROUND

• Kilty SJ, Al-Hajry M, Al-Mutairi D, Bonaparte JP, Duval M, Hwang E, Tse D. Prospective clinical trial of gelatin-thrombin matrix as first line treatment of posterior epistaxis. Laryngoscope. 2014 Jan;124(1):38-42. doi: 10.1002/lary.24240. Epub 2013 Jun 28.

  PMID: 23754469 BACKGROUND

• Warner L, Halliday J, James K, de Carpentier J. Domiciliary floseal prevents admission for epistaxis in hereditary hemorrhagic telangiectasia. Laryngoscope. 2014 Oct;124(10):2238-40. doi: 10.1002/lary.24701. Epub 2014 May 2. No abstract available.

  PMID: 24706356 BACKGROUND

• Geirdal AO, Dheyauldeen S, Bachmann-Harildstad G, Heimdal K. Quality of life in patients with hereditary hemorrhagic telangiectasia in Norway: a population based study. Am J Med Genet A. 2012 Jun;158A(6):1269-78. doi: 10.1002/ajmg.a.35309. Epub 2012 Apr 23.

  PMID: 22529055 BACKGROUND

• Geisthoff UW, Heckmann K, D'Amelio R, Grunewald S, Knobber D, Falkai P, Konig J. Health-related quality of life in hereditary hemorrhagic telangiectasia. Otolaryngol Head Neck Surg. 2007 May;136(5):726-33; discussion 734-5. doi: 10.1016/j.otohns.2006.12.019.

  PMID: 17478205 BACKGROUND

• Jameson M, Gross CW, Kountakis SE. FloSeal use in endoscopic sinus surgery: effect on postoperative bleeding and synechiae formation. Am J Otolaryngol. 2006 Mar-Apr;27(2):86-90. doi: 10.1016/j.amjoto.2005.07.011.

  PMID: 16500469 BACKGROUND

• Lee JM, Wu V, Faughnan ME, Lasso A, Figol A, Kilty SJ. Prospective pilot study of Floseal(R) for the treatment of anterior epistaxis in patients with hereditary hemorrhagic telangiectasia (HHT). J Otolaryngol Head Neck Surg. 2019 Oct 15;48(1):48. doi: 10.1186/s40463-019-0379-y.

  PMID: 31615556 DERIVED

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic; Epistaxis

Interventions

FloSeal Matrix; Drug Packaging

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Technology, Pharmaceutical; Investigative Techniques; Drug Industry; Manufacturing Industry; Industry; Technology, Industry, and Agriculture; Product Packaging

Results Point of Contact

• Title: Dr. John Lee
• Organization: St. Michael's Hospital

John.Lee@unityhealth.to

416-864-5306

Study Officials

• John Lee, MD, MSc

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: December 22, 2015
• Study Start: December 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 28, 2020
• Results First Posted: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)