Trial Outcomes & Findings for Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis (NCT NCT00814333)
NCT ID: NCT00814333
Last Updated: 2016-01-15
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
baseline, day 4-6
Results posted on
2016-01-15
Participant Flow
Participant milestones
| Measure |
Merocel Pack
Standard of care for persons being treated for epistaxis.
Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps
|
Thrombin-JMI
Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
|
|---|---|---|
|
Enrollment
STARTED
|
1
|
0
|
|
Enrollment
COMPLETED
|
0
|
0
|
|
Enrollment
NOT COMPLETED
|
1
|
0
|
|
Treatment Period
STARTED
|
0
|
0
|
|
Treatment Period
COMPLETED
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Merocel Pack
Standard of care for persons being treated for epistaxis.
Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps
|
Thrombin-JMI
Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
|
|---|---|---|
|
Enrollment
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
Baseline characteristics by cohort
| Measure |
Merocel Pack
n=1 Participants
Standard of care for persons being treated for epistaxis.
Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps
|
Thrombin-JMI
Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Gender
Female
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Gender
Male
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, day 4-6Population: No participants started treatment on this study. Study was closed before any study related procedures were administered.
Outcome measures
Outcome data not reported
Adverse Events
Merocel Pack
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Thrombin-JMI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place