Epistaxis
Conditions
Brief 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.
Interventions
DRUGTranexamic 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.
OTHERPlacebo
This group will receive pledget soaked in saline. Protocol will continue as with TXA group.
Sponsors
Mercy Health Ohio
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Patients 18 years and older with anterior epistaxis
Exclusion criteria
* Patients with inability to give consent * Patients without a working telephone number * Patients lacking the mental capacity to make their own decisions * Patients with posterior epistaxis * Epistaxis following major trauma * Patients with known bleeding disorder like hemophilia and thrombocytopenia * Prisoners * Patients hemodynamically unstable * Pregnant patients * Patients with a known allergy to TXA * Patients with a visibly bleeding vessel * Those recently post-op nasal/sinus surgery (within ten days) will also be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding cessation | 15 minutes | After 15 minutes of patient receiving either pledget filled TXA or placebo, bleeding will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction: 10 point scale | Before ED discharge (up to 24 hours) and 1 week after ED discharge | Patient satisfaction will be assessed at the end of the emergency department encounter, and then again via telephone call one week after discharge using a 10 point scale |
| Bleeding cessation | 1 week | Patients will be contacted 1 week after ED discharge to determine whether there was a recurrence of his/her epistaxis |
Countries
United States
Outcome results
None listed