Management of Persistent Epistaxis Using Floseal Hemostatic Matrix

NCT02488135 | Completed Results

• 1 other identifier: 6601059
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Nosebleeds that persist even after adequate traditional nasal packing may require aggressive treatment strategies to stop bleeding. Currently these strategies include a surgical approach to cut off blood supply to the vessel that is bleeding. FloSeal Hemostatic matrix is a gel like medical therapy that is inserted into the nose and is engineered to stop bleeding in severe cases, possibly avoiding the need for surgery. In this study the investigators will randomize patients to either receive FloSeal Hemostatix matrix or traditional nasal packing as a treatment for severe nosebleeds. The main outcome will be whether the investigators are able to stop bleeding with FloSeal or traditional packing alone and whether additional measures are necessary to stop the bleeding. The investigators will also perform a patient comfort survey and cost analysis. Even if FloSeal has equal effectiveness in treating nosebleeds as traditional packing, if it is much more comfortable for patients then it may be the favourable treatment.

Conditions

Epistaxis

Keywords

Floseal® (Baxter, USA); epistaxis; nasal packing; persistent

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Initial Hemostasis

  Residents administering the treatments will empirically observe primary hemostasis. Any active bleeding requiring further intervention within 4 hours of treatment will be defined as failure of initial hemostasis.

  4 hours

Secondary Outcomes (1)

• Patient Pain Level

  48 hours

Study Arms (2)

Floseal Hemostatic Matrix

EXPERIMENTAL

Patients will receive Floseal Hemostatic Matrix topically at the location of active bleeding. Floseal is a gel-like fibrin glue that is applied using a syringe and forms a hemostatic clot.

Device: Floseal Hemostatic Matrix

Traditional Nasal Packing

ACTIVE COMPARATOR

Patients will receive traditional nasal packing to try and abort bleeding. This includes either vaseline gauze or nasal merocels being inserted into the anterior nasal cavity using forceps. These expand upon contact with blood or liquid therefore creating a compression type hemostasis.

Procedure: Traditional Nasal Packing

Interventions

Floseal Hemostatic Matrix DEVICE

Floseal Hemostatic Matrix is a gel like fibrin glue used topically in the nasal cavity and applied with a syringe.

Floseal Hemostatic Matrix

Traditional Nasal Packing PROCEDURE

Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps.

Traditional Nasal Packing

Eligibility Criteria

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

You may qualify if:

• All patients age 18+ presenting with epistaxis that requires an ENT consult that had a first attempt at treatment by an emergency physician.

You may not qualify if:

• Patients will be excluded based on the presence of a hypo-coagulable state. Including patients actively taking anti-coagulant medications or other patients with either acquired or hereditary bleeding disorders.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (1)

• Murray S, Mendez A, Hopkins A, El-Hakim H, Jeffery CC, Cote DWJ. Management of Persistent Epistaxis Using Floseal Hemostatic Matrix vs. traditional nasal packing: a prospective randomized control trial. J Otolaryngol Head Neck Surg. 2018 Jan 8;47(1):3. doi: 10.1186/s40463-017-0248-5.

  PMID: 29310703 DERIVED

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Limitations and Caveats

Lack of blinding to either patient or practitioner. 30 day follow-up limit on outcomes and adverse events

Results Point of Contact

• Title: Scott Murray
• Organization: University of Alberta

sipmurray@gmail.com

587-891-6240

Study Officials

• David Cote, MD, FRCS(C)

  Alberta Health services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 2, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: January 18, 2023
• Results First Posted: January 18, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)