Trial Outcomes & Findings for Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department (NCT NCT02930941)
NCT ID: NCT02930941
Last Updated: 2021-11-30
Results Overview
Time to control of bleeding was defined as the time from the start of enrollment and direct pressure and administration of study drug to the resolution of bleeding
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
35 participants
Primary outcome timeframe
During emergency department (ED) visit
Results posted on
2021-11-30
Participant Flow
Participant milestones
| Measure |
Tranexamic Acid (100 mg/mL)
TXA (100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
Tranexamic Acid: TXA (100 mg/1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
0.9% Sodium Chloride
0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
0.9% Sodium Chloride: 0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Tranexamic Acid (100 mg/mL)
TXA (100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
Tranexamic Acid: TXA (100 mg/1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
0.9% Sodium Chloride
0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
0.9% Sodium Chloride: 0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TXA Group
n=17 Participants
Patients that received tranexamic (TXA)(100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
NS Group
n=18 Participants
Patients that received 0.9% Sodium Chloride (NS) (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Platelet
|
210.1 x10^3 per microliter
n=17 Participants
|
248 x10^3 per microliter
n=18 Participants
|
229.8 x10^3 per microliter
n=35 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=17 Participants
|
9 Participants
n=18 Participants
|
16 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=17 Participants
|
9 Participants
n=18 Participants
|
19 Participants
n=35 Participants
|
|
Age, Continuous
|
61 years
n=17 Participants
|
62 years
n=18 Participants
|
62 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=17 Participants
|
12 Participants
n=18 Participants
|
18 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=17 Participants
|
6 Participants
n=18 Participants
|
17 Participants
n=35 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
17 participants
n=17 Participants
|
18 participants
n=18 Participants
|
35 participants
n=35 Participants
|
|
Past Medical History
Anemia
|
1 Participants
n=17 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=35 Participants
|
|
Past Medical History
Atrial Fbrillation or flutter
|
4 Participants
n=17 Participants
|
2 Participants
n=18 Participants
|
6 Participants
n=35 Participants
|
|
Past Medical History
Cancer
|
2 Participants
n=17 Participants
|
2 Participants
n=18 Participants
|
4 Participants
n=35 Participants
|
|
Past Medical History
Chronic Kidney Disease
|
5 Participants
n=17 Participants
|
2 Participants
n=18 Participants
|
7 Participants
n=35 Participants
|
|
Past Medical History
Congestive Heart Failure
|
4 Participants
n=17 Participants
|
1 Participants
n=18 Participants
|
5 Participants
n=35 Participants
|
|
Past Medical History
Diabetes
|
4 Participants
n=17 Participants
|
6 Participants
n=18 Participants
|
10 Participants
n=35 Participants
|
|
Past Medical History
Hyperlipidemia
|
5 Participants
n=17 Participants
|
5 Participants
n=18 Participants
|
10 Participants
n=35 Participants
|
|
Past Medical History
Ischemic Stroke
|
1 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=35 Participants
|
|
Past Medical History
Obesity
|
2 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=35 Participants
|
|
Past Medical History
Pulmonary Embolism
|
0 Participants
n=17 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=35 Participants
|
|
Past Medical History
Deep Vein Thrombosis
|
0 Participants
n=17 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=35 Participants
|
|
Past Medical History
Myocardial infarction
|
1 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=35 Participants
|
|
Past Medical History
Coronary Artery Bypass
|
1 Participants
n=17 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=35 Participants
|
|
Past Medical History
Hypertension
|
11 Participants
n=17 Participants
|
7 Participants
n=18 Participants
|
18 Participants
n=35 Participants
|
|
Antiplatelet
Aspirin
|
8 Participants
n=17 Participants
|
2 Participants
n=18 Participants
|
10 Participants
n=35 Participants
|
|
Antiplatelet
Clopidogrel
|
2 Participants
n=17 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=35 Participants
|
|
Antiplatelet
Prasugrel
|
1 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=35 Participants
|
|
Antiplatelet
Ticagrelor
|
1 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=35 Participants
|
|
Anticoagulation
Warfarin
|
4 Participants
n=17 Participants
|
2 Participants
n=18 Participants
|
6 Participants
n=35 Participants
|
|
Anticoagulation
Apixaban
|
3 Participants
n=17 Participants
|
2 Participants
n=18 Participants
|
5 Participants
n=35 Participants
|
|
Anticoagulation
Rivaroxaban
|
0 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=35 Participants
|
|
Anticoagulation
Dabigatran
|
0 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=35 Participants
|
|
Hemoglobin
|
12.9 g/dL
n=17 Participants
|
12 g/dL
n=18 Participants
|
12.4 g/dL
n=35 Participants
|
|
Hematocrit
|
38 % by volume of hemoglobin in blood
n=17 Participants
|
35.8 % by volume of hemoglobin in blood
n=18 Participants
|
36.9 % by volume of hemoglobin in blood
n=35 Participants
|
PRIMARY outcome
Timeframe: During emergency department (ED) visitPopulation: Intention-to-treat
Time to control of bleeding was defined as the time from the start of enrollment and direct pressure and administration of study drug to the resolution of bleeding
Outcome measures
| Measure |
TXA Group
n=17 Participants
Tranexamic (TXA)(100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
NS Group
n=18 Participants
0.9% Sodium Chloride (NS) (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
|---|---|---|
|
Time to Control of Bleeding (Minutes, Median, Interquartile Range)
|
64 minutes
Interval 33.0 to 104.0
|
42 minutes
Interval 26.0 to 131.0
|
SECONDARY outcome
Timeframe: During emergency department (ED) visitPopulation: Intention to treat
Length of stay was defined as time from enrollment in study to discharge from the emergency department
Outcome measures
| Measure |
TXA Group
n=17 Participants
Tranexamic (TXA)(100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
NS Group
n=18 Participants
0.9% Sodium Chloride (NS) (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
|---|---|---|
|
Length of Stay in the Emergency Department (Minutes, Median, Inter-Quartile Range)
|
268 minutes
Interval 195.0 to 607.0
|
346 minutes
Interval 283.0 to 410.0
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Intention to treat. Lost to follow up: 1 in TXA group and 1 in NS group
The number of participants with re-bleeding at 24 Hours was evaluated during follow up phone call
Outcome measures
| Measure |
TXA Group
n=16 Participants
Tranexamic (TXA)(100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
NS Group
n=17 Participants
0.9% Sodium Chloride (NS) (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
|---|---|---|
|
Number of Participants With Re-bleeding at 24 Hours
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Intention-to-treat. Loss to follow-up: 1 in TXA group and 2 in NS group
The number of participants with re-bleeding at one week was evaluated during the follow-up phone call
Outcome measures
| Measure |
TXA Group
n=16 Participants
Tranexamic (TXA)(100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
NS Group
n=16 Participants
0.9% Sodium Chloride (NS) (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
|---|---|---|
|
Number of Participants With Re-bleeding at One Week
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Intention to treat. Lost to follow up of 1 in TXA group and 2 in NS group.
Patient reported thromboembolic events during follow-up phone calls at 24 hours and at one week
Outcome measures
| Measure |
TXA Group
n=16 Participants
Tranexamic (TXA)(100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
NS Group
n=16 Participants
0.9% Sodium Chloride (NS) (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
|---|---|---|
|
Thromboembolism
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: during emergency department (ED) visitPopulation: Intention to treat
Patient-reported drug-related adverse events during ED visit
Outcome measures
| Measure |
TXA Group
n=17 Participants
Tranexamic (TXA)(100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
NS Group
n=18 Participants
0.9% Sodium Chloride (NS) (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
|---|---|---|
|
Drug-Related Adverse Events
Nasal irritation
|
0 Participants
|
0 Participants
|
|
Drug-Related Adverse Events
Unpleasant taste
|
1 Participants
|
0 Participants
|
|
Drug-Related Adverse Events
Nasal burning
|
2 Participants
|
0 Participants
|
Adverse Events
TXA Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
NS Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TXA Group
n=17 participants at risk
Patients that received tranexamic (TXA)(100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
NS Group
n=18 participants at risk
Patients that received 0.9% Sodium Chloride (NS) (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
|
|---|---|---|
|
General disorders
Nasal Burning
|
11.8%
2/17 • Number of events 2 • One week from initial ED visit
All adverse effects reported from patients were collected. Mortality was not collected beyond 7 days.
|
0.00%
0/18 • One week from initial ED visit
All adverse effects reported from patients were collected. Mortality was not collected beyond 7 days.
|
|
General disorders
Unpleasant taste
|
5.9%
1/17 • Number of events 1 • One week from initial ED visit
All adverse effects reported from patients were collected. Mortality was not collected beyond 7 days.
|
0.00%
0/18 • One week from initial ED visit
All adverse effects reported from patients were collected. Mortality was not collected beyond 7 days.
|
|
Gastrointestinal disorders
Rhinorrhea
|
5.9%
1/17 • Number of events 1 • One week from initial ED visit
All adverse effects reported from patients were collected. Mortality was not collected beyond 7 days.
|
0.00%
0/18 • One week from initial ED visit
All adverse effects reported from patients were collected. Mortality was not collected beyond 7 days.
|
Additional Information
Aimee Moulin, MD
University of California, Davis Medical Center
Phone: 916-703-6110
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place