A Phase 2 interventional study of Tranexamic Acid and Placebo in Epistaxis, sponsored by Mercy Health Ohio. Suspended at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-11.
Sponsored by Mercy Health Ohio · Phase 2, Interventional, and Treatment
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).
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.
91 studies on the registry are indexed under Epistaxis; 20 are open to participants now.
This study's planned enrollment of 86 is above the median of 60 across 75 interventional studies indexed under Epistaxis.
Browse Epistaxis studies →Mercy Health Ohio is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Research participants in the experimental group will receive one dose of 100mg/mL TXA soaked in a cotton pledget in the bleeding nare for a total of 15 minutes.
Drug: Tranexamic Acid
Research participants in the placebo group will receive one dose of normal saline (0.9%) soaked in a cotton pledget in the bleeding nare for a total of 15 minutes.
Other: Placebo
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.
Also known as: TXA
This group will receive pledget soaked in saline. Protocol will continue as with TXA group.
Also known as: Normal saline
Bleeding cessation
After 15 minutes of patient receiving either pledget filled TXA or placebo, bleeding will be assessed
Time frame: 15 minutes
Patient satisfaction: 10 point scale
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
Time frame: Before ED discharge (up to 24 hours) and 1 week after ED discharge
Bleeding cessation
Patients will be contacted 1 week after ED discharge to determine whether there was a recurrence of his/her epistaxis
Time frame: 1 week
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This study is suspended, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Mercy Health Ohio