NCT04054687

Intranasal TXA for Anterior Epistaxis in the Emergency Department

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Mercy Health Ohio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the efficacy of and patient satisfaction with the use of intranasal tranexamic acid (TXA) for anterior nosebleeds in the emergency department (ED).

Detailed description

Pledget soaked in either saline or TXA will be applied to the bleeding nare of the patient presenting with anterior epistaxis. After fifteen minutes, the pledget will be removed and patient reassessed. Informed consent will be obtained prior to patient enrollment. Enrolled patients will be placed in one of two groups: either the group receiving a cotton pledget soaked in (0.9%) saline or (100mg/1mL) TXA. Patients will initially be asked to gently blow their nose to remove any clots. Group 1 will receive the saline soaked pledget. After fifteen minutes the pledget will be removed. If patient continues to bleed within a reevaluation period of fifteen minutes, this will be deemed a 'failure' and the examiner will pack the nose with the method of his or her choice. Group 2 will receive the TXA soaked pledget and the procedure will continue like Group 1. Patient satisfaction will be assessed in both groups during ED stay and one week after ED stay.

Conditions

• Epistaxis

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Enrolled patients will be placed in one of two groups: either the group receiving a cotton pledget soaked in (0.9%) saline or (100mg/1mL) TXA. Patients will initially be asked to gently blow their nose to remove any clots. Group 1 will receive the saline soaked pledget. After fifteen minutes the pledget will be removed. If patient continues to bleed within a reevaluation period of fifteen minutes, this will be deemed a 'failure' and the examiner will pack the nose with the method of his or her choice. Group 2 will receive the TXA soaked pledget and the procedure will continue like Group 1.
OTHER	Placebo	This group will receive pledget soaked in saline. Protocol will continue as with TXA group.

Timeline

• Start date: 2019-11-07
• Primary completion: 2021-04-01
• Completion: 2021-05-01
• First posted: 2019-08-13
• Last updated: 2020-09-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study