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The Laryngoscope

C 2013 The American Laryngological, V

Rhinological and Otological Society, Inc.

Prospective Clinical Trial of Gelatin-Thrombin Matrix as First Line Treatment of Posterior Epistaxis
Shaun J. Kilty, MD; Mohammad Al-Hajry, MD; Dakheelallah Al-Mutairi, MD; James P. Bonaparte, MSc, MD; Melanie Duval, MD; Euna Hwang, MD; Darren Tse, MD
Objectives/Hypothesis: To evaluate the effectiveness of gelatin-thrombin matrix for first line treatment of posterior epistaxis. Secondarily, we evaluated discomfort during treatment and the cost savings of treatment with gelatin-thrombin matrix compared to posterior packing, endoscopic, or endovascular treatment at our institution. Study Design: Prospective pilot, nonblinded, noncontrolled registered clinical trial (NCT01098578). Methods: Twenty patients with posterior epistaxis were enrolled into this study. Gelatin-thrombin matrix was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion. Patients were discharged within 2 hours of being successfully treated. A visual analog scale (range 010) was used to assess treatment discomfort. Patients were evaluated in clinic 5 and 30 days after treatment to assess for intranasal complications and recurrent epistaxis. Results: Gelatin-thrombin matrix successfully treated epistaxis in 80% of the patients. The procedure was associated with a mean discomfort of 3.6 (range 09.7). The institutional per case cost of treatment of patients with posterior epistaxis with gelatin-thrombin matrix is 80.3%, 87.4%, and 89.4% less than with endoscopic surgery, posterior packing, or embolization, respectively. There were no complications. Conclusion: This pilot study demonstrated that gelatin-thrombin matrix is a safe and both a clinically effective and costsaving means of treating posterior epistaxis. In this study, its use is associated with a low level of discomfort. This treatment method may improve the quality of care for patients with posterior epistaxis. Key Words: Gelatin-thrombin matrix, clinical trial. Level of Evidence: 4. Laryngoscope, 00:000000, 2013

INTRODUCTION
Epistaxis is a common problem often seen in the emergency department (ED). It is relatively benign in nature but can produce both serious and potentially lifethreatening complications. Up to 60% of the population is estimated to have at least one episode of epistaxis during a lifetime.1 Although less than 10% of these patients visit a physician for epistaxis, it remains one of the most common ED-presenting complaints.2,3 Annually, 14.9 individuals per 10,000 population require attention by a physician for a nosebleed; and 1.6

From the Department of OtolaryngologyHead and Neck Surgery (S.J.K., M.A-H, J.P.B., M.D., E.H., D.T.), The University of Ottawa; The Ottawa Hospital (S.J.K., M.A-H., J.P.B., M.D., E.H., D.T.); The Ottawa Hospital Research Institute (OHRI) (S.J.K.), Ottawa, Canada; and the Department of OtolaryngologyHead and Neck Surgery (D.A-M.), King Abdulaziz Medical City, Jeddah, Saudi Arabia. Editors Note: This Manuscript was accepted for publication May 16, 2013. Accepted for Presentation at the 20th International Federation of Otolaryngological Societies (IFOS) World Congress, Seoul, Korea, June 15, 2013. This study is an investigator-initiated clinical trial funded by a research grant from Baxter Corp. The authors have no other funding, financial relationships, or conflicts of interest to disclose. Send correspondence to Dr. Shaun Kilty, Department of OtolaryngologyHead and Neck Surgery, Ottawa Hospital, Civic Campus, Parkdale Clinic, Room 242, 1053 Carling Ave., Ottawa, ON, Canada. E-mail: kiltysj@gmail.com DOI: 10.1002/lary.24240

per 10,000 population require hospitalization because of severe bleeding, mainly due to posterior epistaxis.3 Up to 10% of epistaxis is posterior in nature, which often presents as massive nasal bleeding that is bilateral.1 Currently, there are three treatments that are largely utilized to treat posterior epistaxis. Posterior packing is the conventional treatment for posterior epistaxis, but it requires the patient to be hospitalized in a high cost intensive care or step down unit.4,5 It is associated with significant morbidity, and there is an epistaxis recurrence rate of 30% to 50%.5,6 In contrast, endoscopic treatment of the sphenopalatine artery is an alternative that requires a shorter hospitalization period in a non-ICU bed, and overall it has a lower case cost compared to posterior packing.7,8 It is very successful, with a failure rate of 10% to 15%.913 However, only 50% of otolaryngology residents in their final year of training are comfortable performing this procedure.14 Furthermore, up to 50% of general otolaryngologists are not comfortable performing this procedure in comparison to a comfort level of 100% of surveyed rhinologists.15 For this reason, in many communities this treatment is not available to patients who present with posterior epistaxis. Endovascular selective embolization has a success rate of 86% to 100%; however, it requires significant equipment and expertise.1620 This treatment is also the most costly of the main posterior epistaxis treatment Kilty et al.: Gelatin-Thrombin Matrix for Posterior Epistaxis

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modalities.17 Clearly, despite these three popular treatment modalities there is a need for a less costly yet efficacious treatment of low morbidity for patients who present with posterior epistaxis. Floseal (Baxter Corporation, Deerfield, IL), is a biodegradable hemostatic matrix composed of bovinederived gelatin particles and human-derived thrombin. It has been used for bleeding during endoscopic sinus surgery and it has been demonstrated to be an effective treatment for anterior epistaxis.2,21,22 It is efficacious for hemorrhage control during numerous forms of surgery, including cardiothoracic surgery, hepatic resection, urologic surgery for renal resection, neurosurgery, and gynecology, among others.2330 Gelatin-thrombin matrix is a potentially useful agent for the treatment of posterior epistaxis as it is easy to apply and conforms well to irregular bleeding surfaces. It is hydrophilic and therefore adheres well to wet tissue. However, its use in posterior epistaxis has had limited valuation.31 The primary purpose of this study is to evaluate the effectiveness of gelatin-thrombin matrix as first-line treatment for posterior epistaxis when applied without endoscopic visualization. The secondary objectives were to evaluate the amount of discomfort that patients treated with the described gelatin-thrombin matrix technique for posterior epistaxis sustained, and to evaluate the cost of treating a patient with gelatin-thrombin matrix compared to posterior packing, surgical endoscopic treatment, or embolization treatment at our institution.

MATERIALS AND METHODS Subjects


Those patients offered enrollment into this study had to meet the inclusion criteria of being 18 years of age or older and having been diagnosed with posterior epistaxis either in the ED or as an inpatient within The Ottawa Hospital. Patients with a known sensitivity to any of the materials of gelatin-thrombin matrix, or the topical medications administered as part of the evaluation and treatment of epistaxis (lidocaine, xylometazoline hydrochloride), or pregnant and/or breast feeding women were excluded. Informed consent was obtained from all of the patients. The Ottawa Hospital Research Ethics Board approved the protocol prior to patient enrollment.

Study Design
This was a prospective pilot, nonblinded, noncontrolled registered clinical trial with the U.S. National Institutes of Health (NCT01098578). Posterior epistaxis was operationally defined as nasal bleeding that occurred posterior to the anterior limit of the middle turbinate (i.e., the site of bleeding cannot be identified using anterior rhinoscopy). There had to be active hemorrhage to be enrolled into the study. Patients who presented to the ED with posterior epistaxis were investigated and managed by the ED physician to treat hypertension, coagulopathy, or any other comorbid factors. Any patient who was already admitted to hospital for another diagnosis and had posterior epistaxis had treatment for any comorbid factors initiated by the admitting service. The study protocol was initiated by the otolaryngologyhead & neck surgery residents after consultation request.

At treatment initiation, lidocaine spray (2%) was administered to topically anesthetize the nasal cavity for have a temporizing packing inserted. A 12 Fr Foley catheter was placed into the posterior nasal cavity and inflated with 5 mL of sterile water on the affected side to temporarily tamponade the bleeding. Preparation of 5 mL of the gelatin-thrombin matrix product was done as per manufacturer instructions. With the product prepared, the Foley catheter was deflated and moved posteriorly, placing it into the nasopharynx such that it occluded the choana to prevent aspiration of the gelatin-thrombin matrix product. If the Foley catheter placed in the posterior nasal cavity did not control the bleeding, it was deflated and moved immediately into the nasopharynx. The gelatin-thrombin matrix syringe with a 2.75-inch 14 Fr angiocatheter was inserted along the floor of the nose until the catheter was fully in the nose. The 5 mL of product was then applied into the posterior nasal cavity. The treating physician allowed the product to work for 10 minutes by maintaining the position of the inflated Foley catheter in the nasopharynx. The patient was then reassessed for active bleeding. If bleeding continued, a second syringe of gelatin-thrombin matrix was applied. If the bleeding had stopped following application of the gelatin-thrombin matrix, a 50-cc syringe with sterile saline was used to irrigate the treated nasal cavity to remove any excess gelatin-thrombin matrix product, as per manufacturer recommendations. This was done with the patients head tilted inferiorly 30 degrees so that the irrigation and excess product were removed from the nasal cavity. Once the irrigation was complete, the Foley catheter was deflated and removed from the nasal cavity. If bleeding was not controlled after gelatinthrombin matrix application, the patient was treated using available standard therapies for posterior epistaxis. At the end of the gelatin-thrombin matrix treatment, the participants then completed a 10 cm Visual Analogue Scale (VAS) to assess pain sustained during gelatin-thrombin matrix treatment protocol. At the left end of the line the words no pain were present, and at the right end the words intolerable pain were written. Patients were monitored for 1 hour with vital signs taken every 30 minutes. After 1 hour, the oropharynx was reinspected. If there was no further bleeding, the patient was discharged. Information on comorbities, posterior epistaxis side, and number of gelatin-thrombin matrix treatments were noted. Laboratory data (partial thromboplastin time and prothrombin time) were recorded when available. Following discharge, patients were examined at 5 and 30 days following treatment. At these visits nasal examination was performed to evaluate for evidence of treatment complications such as obvious nasal infection, synechiae, and recurrence of bleeding. Patients were also contacted by telephone on days 10 and 20 after treatment by one of the investigators and asked about the recurrence of bleeding and treatment used, if bleeding occurred following the gelatin-thrombin matrix treatment. Failure of the treatment protocol for a patient was defined as continued epistaxis after the concurrent use of a maximum of two Floseal syringes, or the recurrence of posterior epistaxis within 14 days of treatment with the study gelatin-thrombin matrix technique. Successful treatment using the gelatinthrombin matrix protocol was any case of posterior epistaxis that stopped following the immediate application of either one or two syringes of gelatin-thrombin matrix, and the epistaxis did not resume within 14 days of the treatment date. In order to determine the institutional cost for the treatment of patients with posterior packing, endoscopic surgery, and endovascular embolization, inpatient and ER visits to The Ottawa Hospital (TOH) between January 2010 and March

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2012, where epistaxis was the most responsible diagnosis, were searched by a performance measurement analyst with the performance office at TOH. The institutional per case cost for treating posterior epistaxis with these modalities was determined by the performance measurement analyst, as was the institutional cost of a patient visit for posterior epistaxis successfully treated with the study protocol using gelatin-thrombin matrix. This includes all direct and indirect costs for materials, space, and employees to treat a patient with posterior epistaxis by each of the aforementioned methods. This does not include any physician billings for any of the procedures as physicians are not remunerated by the institution. For the cost of patients treated with gelatin-thrombin matrix, the cost represents the institutional cost to treat a patient in the emergency department with a diagnosis of posterior epistaxis, plus the cost of the gelatin-thrombin matrix product to the institution if it were purchased. Finally, given that all costs were calculated in Canadian dollars (CAD), they were converted to US dollars (USD) using the current monetary exchange rate (total CAD 3 1.03 5 total USD). Statistical testing was performed for the treatment failure group to identify association between variables. Given the small sample size, Fishers exact test was performed to determine any association with gender, hypertension, anticoagulant use, or diabetes.

RESULTS
Twenty patients were enrolled into the study. The mean age of the patients was 57.8 years (range 26 to 95 years) and 10 patients were female (see Table I). Eleven patients presented with posterior epistaxis on the right side. No patient received reversal therapy for their anticoagulation. Gelatin-thrombin matrix successfully stopped posterior epistaxis in 16 cases (80%). All of these cases received a single gelatin-thrombin matrix treatment. Four patients (20%) required additional treatment after gelatin-thrombin matrix failed to stop posterior epistaxis; two had surgical treatment; and two had posterior packing. No patient complications occurred in this study. Among the patients who failed gelatin-thrombin matrix, three were hypertensive and one was on aspirin.
TABLE I. Baseline Characteristics of Enrolled Patients.
Variable

Anticoagulant use was not significantly associated with treatment failure (P 5 1.0). There was likewise no association with gender (P 5 0.58), hypertension (P 5 1.0), or diabetes (P 5 0.62). The VAS assessment for pain with the gelatin-thrombin matrix treatment had a mean of 3.6 (see Fig. 1). The institutional average per case cost of treating posterior epistaxis is $2,696.69 (USD) with endoscopic surgery, $4,221.97 (USD) with posterior packing, and $5,009.92 (USD) with embolization. The institutional cost of treating posterior epistaxis with the described gelatin-thrombin matrix technique is $532.51 (USD). Endoscopic treatment, posterior packing, and embolization therefore cost $2,164.18, $3,690.46, and $4,477.41 (USD), respectivelymore than the gelatin thrombin matrix technique. For all of the patients treated in this study, the total institution cost was $24,487.53 (USD). The minimal institutional cost of successfully treating all of the study patients with endoscopic surgery would have been $53,933.89 (USD) or 2.2 times the actual expense. In comparison to the other modalities for posterior epistaxis treatment, the institutional cost of treating patients with posterior epistaxis with gelatin-thrombin matrix is 80.3%, 87.4%, and 89.4% less than with endoscopic surgery, posterior packing, or embolization, respectively.

DISCUSSION
Posterior epistaxis is a common presentation for emergency physicians and otolaryngologist. Although rarely associated with patient mortality, the currently available treatments are not without significant potential morbidity and cost. As seen in this study, patients tend to be older (mean age of 57.8), and they also typically present with significant comorbidities such as coronary artery disease (35%), hypertension (65%), and diabetes (25%). Anticoagulant use is noted to be prominent in these patients, and 35% of this patient cohort

Patients n Age mean (range) Male:female Posterior epistaxis side right:left Comorbidities n (%) Hypertension Diabetes CAD Anticoagulant Therapy n (%) Aspirin Aspirin 1 clopidrogel Warfarin
CAD 5 coronary artery disease.

20 57.8 (2695) 10:10 11:9 13 (65) 5 (25) 7 (35) 3 (15) 3 (15) 1 (20) Fig. 1. Visual analogue scores (VAS) for procedural pain of patients treated with gelatin-thrombin matrix for posterior epistaxis.

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was on an anticoagulant. Nonetheless, only one of the four patients who failed treatment was on an anticoagulant, specifically aspirin. Therefore, there was no association with treatment failure and anticoagulant use in this study. The current popular methods of posterior epistaxis treatment are associated with a significant cost. Similarly, there are significant morbidities associated with these treatments. These morbidities are not uncommon in patients treated with posterior packing. In this study, there was a 20% failure rate of the gelatin-thrombin matrix treatment technique. In comparison to the published failure rate for posterior nasal packing (at least 30%), the gelatin-thrombin matrix technique has an acceptable failure rate, and as utilized in this study can be applied with a technique that is very similar to that used for posterior nasal packing.5,6 In addition, a pilot study using an endoscopic application technique for gelatin-thrombin matrix also had a 20% failure rate.31 This implies that a less technical approach to gelatinthrombin matrix application, as used in this study, may be equally efficacious. This study demonstrated that, when successfully applied and hemostasis is achieved, patients who are treated with gelatin-thrombin matrix as first line therapy for posterior epistaxis can be discharged from the hospital within 1 hour of treatment. No patient had recurrence of posterior epistaxis once discharged from the ED, if it was successfully treated with the gelatinthrombin matrix application. Early patient discharge lead to a substantial institutional cost reduction for the management of posterior epistaxis, in comparison to posterior packing, endoscopic surgery, or endovascular embolization. Not only was this treatment effective and economically valuable, but it could be performed with generally mild discomfort, as demonstrated by the low VAS scores. Of importance, it was residents in years 3 to 5 of their otolaryngology training who treated the patients in this study. Therefore, this technique should be generalizable to other physicians who currently treat posterior epistaxis using posterior nasal packing. As shown in this study, the technique can be performed with minimal morbidity. There are several limitations to this study that must be acknowledged. As pilot study, it cannot identify treatment outcome superiority of the gelatin-thrombin matrix treatment technique versus any of the other posterior epistaxis treatment methods. Nonetheless, the results of this study support its use and further investigation. It is also important to note that in this trial a 14-ga angiocatheter with a total length 2.75 inches was used so that it could be placed into the posterior nasal cavity to apply and fill the space with gelatin-thrombin matrix. Given that patients were treated only when there was active bleeding (which is typically profuse in the setting of posterior epistaxis) and with a technique that delivered the gelatin-thrombin matrix without visualization of the bleeding site, catheter length is felt to be critical for proper placement of the product and to the overall success of the treatment. Laryngoscope 00: Month 2013

The treatment technique also utilized a Foley catheter to occlude the nasopharynx. It is not known whether this is essential to prevent aspiration of the gelatinthrombin matrix. In contrast, its placement is critical to successful product application; if it is too anteriorly placed, the catheter may prevent contact of the gelatinthrombin matrix with the site of hemorrhage and its successful arrest. Furthermore, it is not known whether it is necessary to wait a full 10 minutes once the gelatinthrombin matrix is applied for successful treatment of posterior epistaxis. The manufacturers instructions note that 10 minutes is the maximum time needed for hemorrhage arrest. However, a treatment time as short as 3 minutes may control hemorrhage. Lastly, surveillance for epistaxis recurrence was done for a total of 30 days. It is possible that a participant could have sustained an episode of posterior epistaxis after this time period. However, whether this would be a recurrence of the initial epistaxis episode or a new event is not known.

CONCLUSION
Posterior epistaxis is a significant medical diagnosis; when treated with any of the conventionally available methods, it is associated with high institutional costs and potential morbidity. Furthermore, most highly successful treatment techniques (endoscopic surgery and embolization) require significant technical expertise, thereby limiting their availability. The gelatin-thrombin matrix application technique used in this study was highly successful; it demonstrated a low morbidity as well a very low institutional cost in comparison to any of the other three treatment modalities. This technique of treatment shows great promise and consideration should be given to using this technique as first line therapy for posterior epistaxis.

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