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

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.

Timeline

Start

2015-12

Primary completion

2019-10

Completion

2019-12

Publications

• Background Sharathkumar AA, Shapiro A. Hereditary haemorrhagic telangiectasia. Haemophilia. 2008 Nov;14(6):1269-80. doi: 10.1111/j.1365-2516.2008.01774.x.
• Background Olitsky SE. Hereditary hemorrhagic telangiectasia: diagnosis and management. Am Fam Physician. 2010 Oct 1;82(7):785-90.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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Indications